{"id":9431,"date":"2026-03-17T10:58:32","date_gmt":"2026-03-17T10:58:32","guid":{"rendered":"https:\/\/sepro.vn\/?p=9431"},"modified":"2026-03-17T10:58:32","modified_gmt":"2026-03-17T10:58:32","slug":"sporicide-diet-bao-tu-la-gi-va-tai-sao-no-khong-the-thieu-trong-phong-sach-gmp","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/sporicide-diet-bao-tu-la-gi-va-tai-sao-no-khong-the-thieu-trong-phong-sach-gmp\/","title":{"rendered":"Sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 g\u00ec v\u00e0 t\u1ea1i sao n\u00f3 kh\u00f4ng th\u1ec3 thi\u1ebfu trong ph\u00f2ng s\u1ea1ch GMP"},"content":{"rendered":"<div class=\"markdown-body MarkdownRenderer-module__container__sJ8jf MarkdownViewer-module__markdownOverrides__sSQCQ\" data-copilot-markdown=\"true\">\n<p>Trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c m\u00f4i tr\u01b0\u1eddng ki\u1ec3m so\u00e1t nghi\u00eam ng\u1eb7t, <a href=\"https:\/\/sepro.vn\/sporicide-diet-bao-tu-la-gi-va-tai-sao-no-khong-the-thieu-trong-phong-sach-gmp\/\"><strong>sporicide di\u1ec7t b\u00e0o t\u1eed<\/strong><\/a> l\u00e0 m\u1ed9t nh\u00f3m h\u00f3a ch\u1ea5t quan tr\u1ecdng trong vi\u1ec7c ki\u1ec3m so\u00e1t b\u00e0o t\u1eed nh\u01b0ng th\u01b0\u1eddng ch\u01b0a \u0111\u01b0\u1ee3c hi\u1ec3u \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 m\u1ee5c \u0111\u00edch v\u00e0 c\u00e1ch s\u1eed d\u1ee5ng. Kh\u00e1c v\u1edbi nhi\u1ec1u ch\u1ea5t kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng ch\u1ec9 c\u00f3 t\u00e1c d\u1ee5ng \u0111\u1ed1i v\u1edbi vi khu\u1ea9n sinh d\u01b0\u1ee1ng, virus ho\u1eb7c n\u1ea5m, sporicidal disinfectants \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 ti\u00eau di\u1ec7t b\u00e0o t\u1eed vi khu\u1ea9n, l\u00e0 d\u1ea1ng vi sinh v\u1eadt c\u00f3 kh\u1ea3 n\u0103ng t\u1ed3n t\u1ea1i trong \u0111i\u1ec1u ki\u1ec7n kh\u1eafc nghi\u1ec7t, kh\u00f3 b\u1ecb ti\u00eau di\u1ec7t v\u00e0 c\u00f3 kh\u1ea3 n\u0103ng ph\u1ee5c h\u1ed3i cao.<\/p>\n<p>B\u00e0i vi\u1ebft n\u00e0y gi\u1ea3i th\u00edch sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 g\u00ec, t\u1ea1i sao ch\u00fang l\u00e0 m\u1ed9t ph\u1ea7n thi\u1ebft y\u1ebfu c\u1ee7a ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n trong ph\u00f2ng s\u1ea1ch theo GMP, c\u00e1ch s\u1eed d\u1ee5ng \u0111\u00fang trong th\u1ef1c h\u00e0nh v\u00e0 c\u00e1ch t\u00edch h\u1ee3p v\u00e0o h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t vi sinh.<\/p>\n<h2><strong>Sporicide l\u00e0 g\u00ec \u2014 \u0110\u1ecbnh ngh\u0129a v\u00e0 ph\u1ea1m vi t\u00e1c d\u1ee5ng<\/strong><\/h2>\n<p>Sporicide, hay <strong>sporicidal disinfectant<\/strong> hay c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed, l\u00e0 t\u00e1c nh\u00e2n h\u00f3a h\u1ecdc c\u00f3 kh\u1ea3 n\u0103ng gi\u1ebft ch\u1ebft ho\u1eb7c v\u00f4 hi\u1ec7u h\u00f3a b\u00e0o t\u1eed vi khu\u1ea9n (bacterial spores) \u0111\u1eb7c bi\u1ec7t l\u00e0 b\u00e0o t\u1eed c\u1ee7a <strong>Bacillus v\u00e0 Clostridium.<\/strong><\/p>\n<p>\u0110\u1ec3 hi\u1ec3u r\u00f5 t\u1ea1i sao di\u1ec7t b\u00e0o t\u1eed quan tr\u1ecdng, c\u1ea7n ph\u00e2n bi\u1ec7t hai tr\u1ea1ng th\u00e1i c\u1ee7a vi khu\u1ea9n:<\/p>\n<p><strong>Vi khu\u1ea9n sinh d\u01b0\u1ee1ng<\/strong>\u00a0l\u00e0 d\u1ea1ng ho\u1ea1t \u0111\u1ed9ng, sinh s\u1ea3n \u0111\u01b0\u1ee3c c\u1ee7a vi khu\u1ea9n. Ch\u00fang c\u00f3 t\u1ebf b\u00e0o m\u1ecfng, ch\u1ee9a \u0111\u1ee7 n\u01b0\u1edbc v\u00e0 c\u00e1c ch\u1ea5t s\u1ed1ng, do \u0111\u00f3 d\u1ec5 b\u1ecb di\u1ec7t b\u1edfi c\u00e1c t\u00e1c nh\u00e2n kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng nh\u01b0 clo, iodine ho\u1eb7c c\u00e1c ch\u1ea5t oxy h\u00f3a.<\/p>\n<p><strong>B\u00e0o t\u1eed vi khu\u1ea9n<\/strong>\u00a0l\u00e0 d\u1ea1ng \u0111\u1eb7c bi\u1ec7t c\u1ee7a vi khu\u1ea9n \u2014 m\u1ed9t v\u1ecf b\u1ea3o v\u1ec7 d\u00e0y, c\u00f3 h\u00e0m l\u01b0\u1ee3ng n\u01b0\u1edbc r\u1ea5t th\u1ea5p v\u00e0 g\u1ea7n nh\u01b0 ng\u1eebng to\u00e0n b\u1ed9 ho\u1ea1t \u0111\u1ed9ng sinh h\u1ecdc. Trong tr\u1ea1ng th\u00e1i n\u00e0y, b\u00e0o t\u1eed c\u00f3 th\u1ec3 ch\u1ecbu \u0111\u1ef1ng nhi\u1ec7t \u0111\u1ed9 cao <strong>(150\u00b0C tr\u1edf l\u00ean)<\/strong>, kh\u00f4 h\u1ea1n, h\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng, th\u1eadm ch\u00ed ti\u1ebfp x\u00fac v\u1edbi c\u00e1c ch\u1ea5t oxy h\u00f3a y\u1ebfu trong th\u1eddi gian d\u00e0i m\u00e0 v\u1eabn s\u1ed1ng s\u00f3t. Khi \u0111i\u1ec1u ki\u1ec7n m\u00f4i tr\u01b0\u1eddng thu\u1eadn l\u1ee3i tr\u1edf l\u1ea1i, b\u00e0o t\u1eed s\u1ebd ph\u1ee5c h\u1ed3i th\u00e0nh vi khu\u1ea9n sinh d\u01b0\u1ee1ng v\u00e0 ti\u1ebfp t\u1ee5c sinh s\u1ea3n.<\/p>\n<p>Ch\u00ednh v\u00ec v\u1eady, c\u00e1c ch\u1ea5t kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng kh\u00f4ng \u0111\u1ee7 hi\u1ec7u l\u1ef1c \u0111\u1ec3 ti\u00eau di\u1ec7t b\u00e0o t\u1eed. Sporicide di\u1ec7t b\u00e0o t\u1eed \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 xuy\u00ean qua l\u1edbp v\u1ecf b\u1ea3o v\u1ec7 c\u1ee7a b\u00e0o t\u1eed v\u00e0 ph\u00e1 h\u1ee7y c\u1ea5u tr\u00fac di truy\u1ec1n b\u00ean trong, khi\u1ebfn b\u00e0o t\u1eed m\u1ea5t kh\u1ea3 n\u0103ng ph\u1ee5c h\u1ed3i.<\/p>\n<h2><strong>Sporicide kh\u00e1c g\u00ec Sterilant \u2014 S\u1ef1 kh\u00e1c bi\u1ec7t c\u1ed1t l\u00f5i<\/strong><\/h2>\n<figure id=\"attachment_9449\" aria-describedby=\"caption-attachment-9449\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-9449\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-4.png\" alt=\"sporicde-vs-sterilant\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-4.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-4-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-4-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/2-4-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9449\" class=\"wp-caption-text\"><em>Kh\u00e1c bi\u1ec7t gi\u1eefa Sporicide v\u00e0 Sterilant<\/em><\/figcaption><\/figure>\n<p>\u0110\u00e2y l\u00e0 m\u1ed9t \u0111i\u1ec3m th\u01b0\u1eddng b\u1ecb nh\u1ea7m l\u1eabn trong th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c. C\u1ea3 sporicide v\u00e0 sterilant \u0111\u1ec1u c\u00f3 kh\u1ea3 n\u0103ng di\u1ec7t b\u00e0o t\u1eed, nh\u01b0ng ch\u00fang kh\u00f4ng ph\u1ea3i c\u00f9ng m\u1ed9t lo\u1ea1i t\u00e1c nh\u00e2n.<\/p>\n<table>\n<thead>\n<tr>\n<th>Ti\u00eau ch\u00ed<\/th>\n<th>Sporicide<\/th>\n<th>Sterilant<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>M\u1ee5c \u0111\u00edch<\/td>\n<td>Gi\u1ea3m t\u1ea3i b\u00e0o t\u1eed, ki\u1ec3m so\u00e1t nhi\u1ec5m<\/td>\n<td>Lo\u1ea1i b\u1ecf ho\u00e0n to\u00e0n vi sinh (v\u00f4 tr\u00f9ng)<\/td>\n<\/tr>\n<tr>\n<td>Ph\u01b0\u01a1ng ph\u00e1p<\/td>\n<td>H\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7p (lau, phun, x\u1ecbt)<\/td>\n<td>H\u00f3a ch\u1ea5t ho\u1eb7c v\u1eadt l\u00fd (nhi\u1ec7t, kh\u00ed)<\/td>\n<\/tr>\n<tr>\n<td>Contact time<\/td>\n<td>T\u1eeb 10-60 ph\u00fat<\/td>\n<td>T\u1eeb v\u00e0i gi\u1edd \u0111\u1ebfn v\u00e0i ng\u00e0y<\/td>\n<\/tr>\n<tr>\n<td>N\u1ed3ng \u0111\u1ed9<\/td>\n<td>N\u1ed3ng \u0111\u1ed9 l\u00e0m vi\u1ec7c ti\u00eau chu\u1ea9n<\/td>\n<td>N\u1ed3ng \u0111\u1ed9 cao, \u0111i\u1ec1u ki\u1ec7n kh\u1eaft khe<\/td>\n<\/tr>\n<tr>\n<td>\u1ee8ng d\u1ee5ng<\/td>\n<td>Kh\u1eed khu\u1ea9n b\u1ec1 m\u1eb7p, thi\u1ebft b\u1ecb h\u00e0ng ng\u00e0y<\/td>\n<td>Ti\u1ec7t khu\u1ea9n d\u1ee5ng c\u1ee5, bao b\u00ec tr\u01b0\u1edbc s\u1eed d\u1ee5ng<\/td>\n<\/tr>\n<tr>\n<td>Hi\u1ec7u qu\u1ea3<\/td>\n<td>Gi\u1ea3m b\u00e0o t\u1eed t\u1eeb 6-7 log<\/td>\n<td>Gi\u1ea3m b\u00e0o t\u1eed 6 log tr\u1edf l\u00ean<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Ngu\u1ed3n tham kh\u1ea3o:<\/strong>\u00a0<a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/brigham-and-womens-hospital-inc-623476-04112022\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/brigham-and-womens-hospital-inc-623476-04112022<\/a><\/p>\n<blockquote><p><strong>\u0110i\u1ec3m c\u1ed1t l\u00f5i:<\/strong> Sporicide kh\u00f4ng ph\u1ea3i l\u00e0 sterilant. Sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t d\u1ef1 ph\u00f2ng nh\u1eb1m duy tr\u00ec m\u1ee9c nhi\u1ec5m th\u1ea5p trong m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch, trong khi sterilant \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 lo\u1ea1i b\u1ecf ho\u00e0n to\u00e0n vi sinh v\u1eadt tr\u00ean d\u1ee5ng c\u1ee5 ho\u1eb7c bao b\u00ec tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o s\u1ea3n xu\u1ea5t.<\/p><\/blockquote>\n<h2><strong>Di\u1ec7t b\u00e0o t\u1eed kh\u00e1c g\u00ec kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng<\/strong><\/h2>\n<p>\u0110\u1ec3 hi\u1ec3u r\u00f5 t\u1ea1i sao di\u1ec7t b\u00e0o t\u1eed l\u1ea1i c\u1ea7n thi\u1ebft, so s\u00e1nh hi\u1ec7u qu\u1ea3 gi\u1eefa kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng v\u00e0 kh\u1eed khu\u1ea9n b\u1eb1ng ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed.<\/p>\n<p><strong>Kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng<\/strong>\u00a0(s\u1eed d\u1ee5ng c\u00e1c ch\u1ea5t nh\u01b0 clo, iodine, alcohol) c\u00f3 t\u00e1c d\u1ee5ng di\u1ec7t vi khu\u1ea9n nhanh. Tuy nhi\u00ean, ch\u00fang g\u1ea7n nh\u01b0 kh\u00f4ng t\u00e1c d\u1ee5ng \u0111\u1ed1i v\u1edbi b\u00e0o t\u1eed v\u00ec kh\u00f4ng xuy\u00ean th\u1ee7ng \u0111\u01b0\u1ee3c v\u1ecf b\u1ea3o v\u1ec7 c\u1ee9ng c\u1ee7a b\u00e0o t\u1eed. K\u1ebft qu\u1ea3 l\u00e0 c\u00e1c b\u00e0o t\u1eed v\u1eabn t\u1ed3n t\u1ea1i tr\u00ean b\u1ec1 m\u1eb7p v\u00e0 c\u00f3 th\u1ec3 ph\u1ee5c h\u1ed3i sau m\u1ed9t th\u1eddi gian.<\/p>\n<p><strong>Kh\u1eed khu\u1ea9n v\u1edbi sporicide di\u1ec7t b\u00e0o t\u1eed<\/strong>\u00a0s\u1eed d\u1ee5ng c\u00e1c h\u00f3a ch\u1ea5t m\u1ea1nh h\u01a1n (nh\u01b0 <strong>hydrogen peroxide 7.5%<\/strong>, glutaraldehyde) v\u1edbi contact time t\u1eeb <strong>10-60 ph\u00fat<\/strong> t\u00f9y v\u00e0o ch\u1ea5t v\u00e0 n\u1ed3ng \u0111\u1ed9. Sporicide di\u1ec7t b\u00e0o t\u1eed xuy\u00ean th\u1ee7ng v\u1ecf b\u00e0o t\u1eed v\u00e0 ph\u00e1 h\u1ee7y c\u1ea5u tr\u00fac b\u00ean trong, l\u00e0m cho b\u00e0o t\u1eed kh\u00f4ng th\u1ec3 ph\u1ee5c h\u1ed3i.<\/p>\n<p><strong>K\u1ebft lu\u1eadn th\u1ef1c t\u1ebf:<\/strong>\u00a0M\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n ph\u00f2ng s\u1ea1ch theo GMP kh\u00f4ng th\u1ec3 ch\u1ec9 d\u1ef1a v\u00e0o kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng. C\u1ea7n k\u1ebft h\u1ee3p kh\u1eed khu\u1ea9n h\u00e0ng ng\u00e0y \u0111\u1ec3 ki\u1ec3m so\u00e1t vi khu\u1ea9n sinh d\u01b0\u1ee1ng, \u0111\u1ed3ng th\u1eddi s\u1eed d\u1ee5ng sporicidal disinfectant \u0111\u1ecbnh k\u1ef3 (h\u00e0ng tu\u1ea7n ho\u1eb7c hai tu\u1ea7n m\u1ed9t l\u1ea7n) \u0111\u1ec3 ki\u1ec3m so\u00e1t b\u00e0o t\u1eed v\u00e0 ng\u0103n ch\u1eb7n s\u1ef1 t\u00edch l\u0169y trong m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch.<\/p>\n<h2><strong>H\u00f3a ch\u1ea5t n\u00e0o c\u00f3 t\u00e1c d\u1ee5ng di\u1ec7t b\u00e0o t\u1eed \u2014 Ph\u1ed5 di\u1ec7t b\u00e0o t\u1eed c\u1ee7a Sporicide<\/strong><\/h2>\n<figure id=\"attachment_9451\" aria-describedby=\"caption-attachment-9451\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9451\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-4.png\" alt=\"hoa-chat-nao-co-tac-dung-diet-khuan\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-4.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-4-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-4-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/3-4-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9451\" class=\"wp-caption-text\"><em>H\u00f3a ch\u1ea5t n\u00e0o c\u00f3 t\u00e1c d\u1ee5ng di\u1ec7t khu\u1ea9n<\/em><\/figcaption><\/figure>\n<p>Kh\u00f4ng ph\u1ea3i t\u1ea5t c\u1ea3 h\u00f3a ch\u1ea5t kh\u1eed khu\u1ea9n \u0111\u1ec1u c\u00f3 kh\u1ea3 n\u0103ng di\u1ec7t b\u00e0o t\u1eed. Ch\u1ec9 m\u1ed9t s\u1ed1 sporicidal disinfectants \u0111\u01b0\u1ee3c ch\u1ee9ng minh c\u00f3 hi\u1ec7u l\u1ef1c \u0111\u1ed1i v\u1edbi b\u00e0o t\u1eed vi khu\u1ea9n.<\/p>\n<p><strong>Hydrogen Peroxide 7.5% &#8211; 35%<\/strong>\u00a0l\u00e0 m\u1ed9t t\u00e1c nh\u00e2n di\u1ec7t b\u00e0o t\u1eed ph\u1ed5 bi\u1ebfn trong ph\u00f2ng s\u1ea1ch GMP. V\u1edbi contact time kho\u1ea3ng <strong>3\u201330 ph\u00fat<\/strong> t\u00f9y n\u1ed3ng \u0111\u1ed9 v\u00e0 y\u00eau c\u1ea7u SOP, hydrogen peroxide c\u00f3 kh\u1ea3 n\u0103ng oxy h\u00f3a m\u1ea1nh v\u00e0 ph\u00e1 h\u1ee7y c\u1ea5u tr\u00fac b\u00e0o t\u1eed. M\u1ed9t \u01b0u \u0111i\u1ec3m quan tr\u1ecdng l\u00e0 s\u1ea3n ph\u1ea9m ph\u00e2n h\u1ee7y ch\u1ec9 g\u1ed3m n\u01b0\u1edbc v\u00e0 oxy, kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng \u0111\u1ed9c h\u1ea1i.<\/p>\n<blockquote><p><strong>Tr\u00ean th\u1ecb tr\u01b0\u1eddng, c\u00e1c nh\u00e3n hi\u1ec7u nh\u01b0 STERIS (6% Hydrogen Peroxide WFI), Ecolab (Klercide Low Residue Peroxide 6%), Contec (HydroKlean 6%), v\u00e0 VAI\/Veltek (STERI-PEROX 6%) \u0111\u1ec1u cung c\u1ea5p c\u00e1c s\u1ea3n ph\u1ea9m hydrogen peroxide v\u1edbi n\u1ed3ng \u0111\u1ed9 t\u01b0\u01a1ng t\u1ef1.<\/strong><\/p><\/blockquote>\n<p><strong>Glutaraldehyde 2-3.5%<\/strong>\u00a0l\u00e0 m\u1ed9t h\u00f3a ch\u1ea5t m\u1ea1nh c\u00f3 t\u00e1c d\u1ee5ng di\u1ec7t b\u00e0o t\u1eed \u1edf n\u1ed3ng \u0111\u1ed9 cao v\u1edbi contact time t\u1eeb 3-10 gi\u1edd. Tuy nhi\u00ean glutaraldehyde c\u00f3 nh\u01b0\u1ee3c \u0111i\u1ec3m l\u00e0 \u0111\u1ed9c t\u00ednh cao v\u1edbi nh\u00e2n vi\u00ean n\u00ean kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng th\u01b0\u1eddng xuy\u00ean trong ph\u00f2ng s\u1ea1ch ho\u1ea1t \u0111\u1ed9ng.<\/p>\n<p><strong>Peracetic Acid (PAA) 0.2-0.35%<\/strong>\u00a0l\u00e0 m\u1ed9t ch\u1ea5t oxy h\u00f3a m\u1ea1nh kh\u00e1c, t\u00e1c d\u1ee5ng di\u1ec7t b\u00e0o t\u1eed nhanh (contact time 10-30 ph\u00fat) v\u00e0 ph\u00e2n h\u1ee7y th\u00e0nh ch\u1ea5t kh\u00f4ng \u0111\u1ed9c h\u1ea1i. PAA \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ng\u00e0y c\u00e0ng ph\u1ed5 bi\u1ebfn trong ph\u00f2ng s\u1ea1ch GMP v\u00ec an to\u00e0n cho nh\u00e2n vi\u00ean h\u01a1n glutaraldehyde.<\/p>\n<blockquote><p><strong>C\u00e1c s\u1ea3n ph\u1ea9m nh\u01b0 STERIS (Spor-Klenz), Contec (PeridoxRTU), v\u00e0 VAI\/Veltek (DECON-SPORE 200 Plus) l\u00e0 c\u00e1c bi\u1ebfn th\u1ec3 peracetic acid + hydrogen peroxide \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng r\u1ed9ng r\u00e3i.<\/strong><\/p><\/blockquote>\n<p><strong>Sodium Hypochlorite (Clo)<\/strong>\u00a0\u1edf n\u1ed3ng \u0111\u1ed9 cao (0.52%-5.25%) c\u0169ng c\u00f3 t\u00e1c d\u1ee5ng sporicidal, nh\u01b0ng y\u1ebfu h\u01a1n so v\u1edbi hydrogen peroxide ho\u1eb7c peracetic acid.<\/p>\n<blockquote><p><strong>C\u00e1c s\u1ea3n ph\u1ea9m nh\u01b0 STERIS (Hypochlorite WFI 0.525% v\u00e0 5.25%), VAI\/Veltek (HYPO-CHLOR 0.52% v\u00e0 5.25%), v\u00e0 Ecolab (Klercide Sporicidal Active Chlorine 0.55%) cung c\u1ea5p c\u00e1c d\u1ea1ng hypochlorite cho ph\u00f2ng s\u1ea1ch.<\/strong><\/p><\/blockquote>\n<p><strong>\u0110i\u1ec3m th\u1ef1c h\u00e0nh:<\/strong> Hydrogen peroxide v\u00e0 peracetic acid l\u00e0 nh\u1eefng l\u1ef1a ch\u1ecdn h\u00e0ng \u0111\u1ea7u cho sporicide di\u1ec7t b\u00e0o t\u1eed trong ph\u00f2ng s\u1ea1ch GMP v\u00ec v\u1eeba hi\u1ec7u qu\u1ea3, v\u1eeba an to\u00e0n, v\u1eeba ph\u00e2n h\u1ee7y s\u1ea1ch kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng \u0111\u1ed9c h\u1ea1i.<\/p>\n<h2><strong>Khi n\u00e0o c\u1ea7n d\u00f9ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed (sporicide) trong ph\u00f2ng s\u1ea1ch<\/strong><\/h2>\n<p>Vi\u1ec7c quy\u1ebft \u0111\u1ecbnh khi n\u00e0o s\u1eed d\u1ee5ng h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed kh\u00f4ng ph\u1ea3i d\u1ef1a tr\u00ean checklist c\u1ed1 \u0111\u1ecbnh m\u00e0 c\u1ea7n d\u1ef1a tr\u00ean chi\u1ebfn l\u01b0\u1ee3c ki\u1ec3m so\u00e1t r\u1ee7i ro vi sinh to\u00e0n di\u1ec7n.<\/p>\n<p>Sporicide di\u1ec7t b\u00e0o t\u1eed c\u1ea7n \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ecbnh k\u1ef3 trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p:<\/p>\n<p><strong>H\u00e0ng tu\u1ea7n ho\u1eb7c hai tu\u1ea7n m\u1ed9t l\u1ea7n trong ph\u00f2ng s\u1ea1ch GMP Grade A v\u00e0 B<\/strong>\u00a0\u0111\u1ec3 ng\u0103n ch\u1eb7n t\u00edch l\u0169y b\u00e0o t\u1eed. T\u1ea7n su\u1ea5t s\u1eed d\u1ee5ng c\u1ea7n d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 r\u1ee7i ro v\u00e0 d\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh, v\u00e0 c\u00f3 th\u1ec3 \u0111i\u1ec1u ch\u1ec9nh n\u1ebfu xu\u1ea5t hi\u1ec7n xu h\u01b0\u1edbng t\u0103ng c\u1ee7a vi sinh v\u1eadt t\u1ea1o b\u00e0o t\u1eed.<\/p>\n<p><strong>Sau c\u00e1c s\u1ef1 ki\u1ec7n c\u00f3 nguy c\u01a1 cao<\/strong>\u00a0nh\u01b0 b\u1ea3o tr\u00ec thi\u1ebft b\u1ecb, thay c\u1ea5u h\u00ecnh \u0111\u01b0\u1eddng \u1ed1ng, ho\u1eb7c ph\u00e1t hi\u1ec7n c\u00e1c d\u1ea5u hi\u1ec7u vi sinh (vi khu\u1ea9n t\u0103ng, n\u1ea5m m\u1ed1c). Sporicide di\u1ec7t b\u00e0o t\u1eed \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 x\u00f3a s\u1ea1ch b\u1ea5t k\u1ef3 b\u00e0o t\u1eed n\u00e0o c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o ho\u1eb7c b\u1ecb k\u00edch ho\u1ea1t trong qu\u00e1 tr\u00ecnh b\u1ea3o tr\u00ec.<\/p>\n<p><strong>Khi k\u1ebft qu\u1ea3 gi\u00e1m s\u00e1t vi sinh m\u00f4i tr\u01b0\u1eddng (environmental monitoring) cho th\u1ea5y m\u1ee9c Bacillus t\u0103ng cao<\/strong>, ngay c\u1ea3 khi ch\u01b0a v\u01b0\u1ee3t gi\u1edbi h\u1ea1n c\u1ea3nh b\u00e1o. \u0110\u00e2y l\u00e0 d\u1ea5u hi\u1ec7u s\u1edbm m\u00e0 ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n c\u1ea7n \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh.<\/p>\n<p><strong>Trong c\u00e1c giai \u0111o\u1ea1n chu\u1ea9n b\u1ecb hay kh\u00f4i ph\u1ee5c l\u1ea1i ph\u00f2ng s\u1ea1ch<\/strong>\u00a0sau th\u1eddi gian ng\u1eebng s\u1ea3n xu\u1ea5t k\u00e9o d\u00e0i.<\/p>\n<blockquote><p><strong>L\u01b0u \u00fd quan tr\u1ecdng:<\/strong>\u00a0S\u1eed d\u1ee5ng sporicide di\u1ec7t b\u00e0o t\u1eed qu\u00e1 th\u01b0\u1eddng xuy\u00ean (h\u00e0ng ng\u00e0y) c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn vi\u1ec7c vi khu\u1ea9n ph\u00e1t tri\u1ec3n kh\u00e1ng t\u00ednh, do \u0111\u00f3 c\u1ea7n c\u00f3 chi\u1ebfn l\u01b0\u1ee3c lu\u00e2n phi\u00ean h\u00f3a ch\u1ea5t (ch\u1ee9a \u1edf ph\u1ea7n ti\u1ebfp theo).<\/p><\/blockquote>\n<h2><strong>Lu\u00e2n phi\u00ean Sporicide Di\u1ec7t B\u00e0o T\u1eed \u2014 Chi\u1ebfn l\u01b0\u1ee3c t\u1ed1i \u01b0u \u0111\u1ec3 tr\u00e1nh kh\u00e1ng t\u00ednh<\/strong><\/h2>\n<p>M\u1ed9t sai l\u1ea7m ph\u1ed5 bi\u1ebfn m\u00e0 nhi\u1ec1u nh\u00e0 m\u00e1y d\u01b0\u1ee3c g\u1eb7p ph\u1ea3i l\u00e0 s\u1eed d\u1ee5ng m\u1ed9t lo\u1ea1i di\u1ec7t b\u00e0o t\u1eed duy nh\u1ea5t trong th\u1eddi gian d\u00e0i. \u0110i\u1ec1u n\u00e0y d\u1eabn \u0111\u1ebfn vi khu\u1ea9n, \u0111\u1eb7c bi\u1ec7t l\u00e0 Bacillus, th\u00edch nghi v\u00e0 gi\u1ea3m \u0111\u1ed9 nh\u1ea1y v\u1edbi h\u00f3a ch\u1ea5t.<\/p>\n<h3><strong>Chi\u1ebfn l\u01b0\u1ee3c lu\u00e2n phi\u00ean h\u00f3a ch\u1ea5t c\u1ea7n \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng d\u1ef1a theo ti\u00eau chu\u1ea9n nh\u01b0 sau:<\/strong><\/h3>\n<p><strong>Chia danh s\u00e1ch sporicide th\u00e0nh 2-3 lo\u1ea1i v\u1edbi c\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng kh\u00e1c nhau.<\/strong>\u00a0V\u00ed d\u1ee5:<\/p>\n<ul>\n<li>tu\u1ea7n 1-2 s\u1eed d\u1ee5ng hydrogen peroxide<\/li>\n<li>tu\u1ea7n 3-4 s\u1eed d\u1ee5ng peracetic acid<\/li>\n<li><strong>T\u1ea5t c\u1ea3<\/strong> \u0111\u1ec1u ph\u1ea3i \u0111\u01b0\u1ee3c lu\u00e2n phi\u00ean theo chu k\u1ef3 \u0111\u00e3 quy \u0111\u1ecbnh trong SOP<\/li>\n<\/ul>\n<p><strong>Trong l\u1ef1a ch\u1ecdn, c\u00e1c nh\u00e0 m\u00e1y c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m t\u1eeb c\u00e1c h\u00e3ng kh\u00e1c nhau. Ch\u1eb3ng h\u1ea1n, d\u00f9ng QT Sporicide ho\u1eb7c STERIS Spor-Klenz (peracetic acid + hydrogen peroxide) v\u00e0o tu\u1ea7n 1-2, sau \u0111\u00f3 lu\u00e2n phi\u00ean v\u1edbi STERIS Hydrogen Peroxide WFI ho\u1eb7c Contec HydroKlean v\u00e0o tu\u1ea7n 3-4, r\u1ed3i quay l\u1ea1i peracetic acid v\u00e0o tu\u1ea7n 5-6.<\/strong><\/p>\n<p><strong>N\u1ed3ng \u0111\u1ed9 v\u00e0 contact time ph\u1ea3i tu\u00e2n theo h\u01b0\u1edbng d\u1eabn c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 SOP \u0111\u00e3 th\u1ea9m \u0111\u1ecbnh<\/strong>, nh\u1eb1m \u0111\u1ea3m b\u1ea3o hi\u1ec7u l\u1ef1c di\u1ec7t b\u00e0o t\u1eed trong \u0111i\u1ec1u ki\u1ec7n v\u1eadn h\u00e0nh th\u1ef1c t\u1ebf.<\/p>\n<blockquote><p><strong>V\u00ed d\u1ee5: hydrogen peroxide 7.5% (nh\u01b0 s\u1ea3n ph\u1ea9m c\u1ee7a STERIS, Contec, VAI\/Veltek) c\u00f3 contact time 10-15 ph\u00fat, trong khi peracetic acid 0.2% (nh\u01b0 Ecolab Klercide, STERIS Spor-Klenz) c\u00f3 contact time 20-30 ph\u00fat.<\/strong><\/p><\/blockquote>\n<p><strong>Ghi ch\u00e9p chi ti\u1ebft t\u1eebng l\u1ea7n s\u1eed d\u1ee5ng:<\/strong>\u00a0lo\u1ea1i h\u00f3a ch\u1ea5t, n\u1ed3ng \u0111\u1ed9 th\u1ef1c t\u1ebf, contact time, khu v\u1ef1c \u00e1p d\u1ee5ng, nh\u00e2n vi\u00ean th\u1ef1c hi\u1ec7n v\u00e0 k\u1ebft qu\u1ea3 gi\u00e1m s\u00e1t vi sinh sau kh\u1eed khu\u1ea9n.<\/p>\n<p><strong>Ph\u00e2n t\u00edch d\u1eef li\u1ec7u xu h\u01b0\u1edbng m\u00f4i tr\u01b0\u1eddng vi sinh h\u00e0ng th\u00e1ng<\/strong>\u00a0\u0111\u1ec3 \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3. N\u1ebfu m\u1ee9c Bacillus kh\u00f4ng gi\u1ea3m ho\u1eb7c xu h\u01b0\u1edbng t\u0103ng, \u0111i\u1ec1u ch\u1ec9nh l\u1ea1i lo\u1ea1i sporicide ho\u1eb7c t\u1ea7n su\u1ea5t s\u1eed d\u1ee5ng.<\/p>\n<p>\u0110\u1ec3 t\u00ecm hi\u1ec3u th\u00eam v\u1ec1 c\u00e1ch x\u00e2y d\u1ef1ng ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n to\u00e0n di\u1ec7n v\u1edbi lu\u00e2n phi\u00ean h\u00f3a ch\u1ea5t \u0111\u00fang chu\u1ea9n theo GMP EU, b\u1ea1n c\u00f3 th\u1ec3 tham kh\u1ea3o:\u00a0<strong><a href=\"https:\/\/sepro.vn\/hoa-chat-khu-khuan-phong-sach-theo-gmp-eu\/\" target=\"_blank\" rel=\"noopener noreferrer\">H\u00f3a Ch\u1ea5t Kh\u1eed Khu\u1ea9n Ph\u00f2ng S\u1ea1ch Theo GMP EU<\/a><\/strong><\/p>\n<h2><strong>Sporicide Di\u1ec7t B\u00e0o T\u1eed D\u00f9ng Cho Ph\u00f2ng S\u1ea1ch GMP<\/strong><\/h2>\n<figure id=\"attachment_9453\" aria-describedby=\"caption-attachment-9453\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img decoding=\"async\" class=\"size-full wp-image-9453\" src=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-4.png\" alt=\"sporicide-diet-bao-tu-dung-cho-phong-sach-gmp\" width=\"600\" height=\"600\" srcset=\"https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-4.png 600w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-4-300x300.png 300w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-4-150x150.png 150w, https:\/\/sepro.vn\/wp-content\/uploads\/2026\/03\/4-4-100x100.png 100w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-9453\" class=\"wp-caption-text\"><em>Sporicide Di\u1ec7t B\u00e0o T\u1eed D\u00f9ng Cho Ph\u00f2ng S\u1ea1ch GMP<\/em><\/figcaption><\/figure>\n<p>Kh\u00f4ng ph\u1ea3i b\u1ea5t k\u1ef3 sporicide di\u1ec7t b\u00e0o t\u1eed n\u00e0o c\u0169ng ph\u00f9 h\u1ee3p v\u1edbi ph\u00f2ng s\u1ea1ch GMP. Vi\u1ec7c l\u1ef1a ch\u1ecdn h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed c\u1ea7n \u0111\u00e1p \u1ee9ng m\u1ed9t s\u1ed1 ti\u00eau ch\u00ed k\u1ef9 thu\u1eadt quan tr\u1ecdng.<\/p>\n<h3><strong>Ti\u00eau ch\u00ed ch\u1ecdn sporicide di\u1ec7t b\u00e0o t\u1eed cho ph\u00f2ng s\u1ea1ch GMP:<\/strong><\/h3>\n<ul>\n<li>Ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m nghi\u1ec7m v\u00e0 c\u00f3 hi\u1ec7u l\u1ef1c ch\u1ee9ng minh di\u1ec7t b\u00e0o t\u1eed theo ti\u00eau chu\u1ea9n (nh\u01b0 ISO 11135 hay ti\u00eau chu\u1ea9n d\u01b0\u1ee3c \u0111i\u1ec3n t\u01b0\u01a1ng \u0111\u01b0\u01a1ng).<\/li>\n<li>Ph\u1ea3i kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng \u0111\u1ed9c h\u1ea1i ho\u1eb7c kh\u00f4ng bay h\u01a1i tr\u00ean b\u1ec1 m\u1eb7p, v\u00ec nh\u1eefng d\u01b0 l\u01b0\u1ee3ng n\u00e0y c\u00f3 th\u1ec3 \u00f4 nhi\u1ec5m s\u1ea3n ph\u1ea9m.<\/li>\n<li>Ph\u1ea3i t\u01b0\u01a1ng th\u00edch v\u1edbi b\u1ec1 m\u1eb7p trong ph\u00f2ng s\u1ea1ch (inox, th\u1ee7y tinh, nh\u1ef1a PVC) v\u00e0 kh\u00f4ng g\u00e2y h\u01b0 h\u1ecfng ho\u1eb7c \u0103n m\u00f2n.<\/li>\n<li>Ph\u1ea3i c\u00f3 th\u1eddi gian ti\u1ebfp x\u00fac r\u00f5 r\u00e0ng \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp qua SOP. V\u00ed d\u1ee5: hydrogen peroxide 7.5% c\u00f3 contact time 10-15 ph\u00fat tr\u01b0\u1edbc khi lau kh\u00f4, peracetic acid 0.2% c\u00f3 contact time 20-30 ph\u00fat.<\/li>\n<li>Ph\u1ea3i c\u00f3 kh\u1ea3 n\u0103ng \u0111\u00e1nh gi\u00e1 hi\u1ec7u qu\u1ea3 qua c\u00e1c ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra (nh\u01b0 l\u00e2m s\u00e0ng ho\u1eb7c gi\u00e1m s\u00e1t vi sinh m\u00f4i tr\u01b0\u1eddng).<\/li>\n<li><strong>\u0110\u1eb7c bi\u1ec7t trong Grade A c\u00f3 y\u00eau c\u1ea7u v\u00f4 tr\u00f9ng, h\u00f3a ch\u1ea5t \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o v\u00e0 s\u1eed d\u1ee5ng ph\u1ea3i \u0111\u1ea3m b\u1ea3o t\u00ednh v\u00f4 tr\u00f9ng (chi\u1ebfu x\u1ea1 gamma) v\u00e0 n\u1ed9i \u0111\u1ed9c t\u1ed1 \u2264 0.25 EU\/mL.<\/strong><\/li>\n<\/ul>\n<h3><strong>G\u1ee3i \u00fd chi\u1ebfn l\u01b0\u1ee3c s\u1eed d\u1ee5ng Sporicide Di\u1ec7t B\u00e0o T\u1eed:<\/strong><\/h3>\n<p>M\u1ed9t chi\u1ebfn l\u01b0\u1ee3c hi\u1ec7u qu\u1ea3 l\u00e0 lu\u00e2n phi\u00ean c\u00e1c lo\u1ea1i sporicide di\u1ec7t b\u00e0o t\u1eed c\u00f3 c\u01a1 ch\u1ebf t\u00e1c d\u1ee5ng kh\u00e1c nhau trong chu k\u1ef3 h\u00e0ng th\u00e1ng.<\/p>\n<blockquote><p><strong>Ch\u1eb3ng h\u1ea1n, d\u00f9ng QT Sporicide (peracetic acid + hydrogen peroxide) v\u00e0o tu\u1ea7n 1-2, sau \u0111\u00f3 lu\u00e2n phi\u00ean v\u1edbi STERIS Hydrogen Peroxide WFI ho\u1eb7c Contec HydroKlean v\u00e0o tu\u1ea7n 3-4. \u0110i\u1ec1u n\u00e0y v\u1eeba duy tr\u00ec hi\u1ec7u qu\u1ea3 di\u1ec7t b\u00e0o t\u1eed, v\u1eeba gi\u1ea3m nguy c\u01a1 vi khu\u1ea9n ph\u00e1t tri\u1ec3n kh\u00e1ng t\u00ednh.<\/strong><\/p><\/blockquote>\n<p><strong>QT Sporicide, v\u1edbi c\u00f4ng th\u1ee9c \u0111\u01b0\u1ee3c t\u1ed1i \u01b0u cho m\u00f4i tr\u01b0\u1eddng ISO 5-6, cho ph\u00e9p th\u1eddi gian ti\u1ebfp x\u00fac ng\u1eafn (10-15 ph\u00fat) m\u00e0 v\u1eabn \u0111\u1ea1t hi\u1ec7u qu\u1ea3 cao, gi\u00fap t\u1ed1i \u01b0u th\u1eddi gian v\u1eadn h\u00e0nh ph\u00f2ng s\u1ea1ch.<\/strong>\u00a0\u0110\u1ec3 t\u00ecm hi\u1ec3u th\u00eam v\u1ec1 c\u00e1c gi\u1ea3i ph\u00e1p sporicide di\u1ec7t b\u00e0o t\u1eed to\u00e0n di\u1ec7n, b\u1ea1n c\u00f3 th\u1ec3 xem:\u00a0<strong><a href=\"https:\/\/sepro.vn\/hoa-chat-khu-trung-quantumtec-giai-phap-toan-dien-cho-moi-truong-kiem-soat-nghiem-ngat\/\" target=\"_blank\" rel=\"noopener noreferrer\">H\u00f3a Ch\u1ea5t Kh\u1eed Tr\u00f9ng QuantumTEC \u2014 Gi\u1ea3i Ph\u00e1p To\u00e0n Di\u1ec7n Cho M\u00f4i Tr\u01b0\u1eddng Ki\u1ec3m So\u00e1t Nghi\u00eam Ng\u1eb7t<\/a><\/strong><\/p>\n<h2><strong>Contact Time C\u1ee7a Sporicide Di\u1ec7t B\u00e0o T\u1eed \u2014 T\u1ea1i sao n\u00f3 quan tr\u1ecdng<\/strong><\/h2>\n<p><strong>Contact time (th\u1eddi gian ti\u1ebfp x\u00fac)<\/strong>\u00a0l\u00e0 kho\u1ea3ng th\u1eddi gian m\u00e0 sporicide di\u1ec7t b\u00e0o t\u1eed ph\u1ea3i ti\u1ebfp x\u00fac v\u1edbi b\u1ec1 m\u1eb7p \u0111\u1ec3 \u0111\u1ea1t hi\u1ec7u qu\u1ea3 di\u1ec7t b\u00e0o t\u1eed. Gi\u00e1 tr\u1ecb n\u00e0y kh\u00f4ng ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ecdn t\u00f9y \u00fd m\u00e0 l\u00e0 k\u1ebft qu\u1ea3 c\u1ee7a c\u00e1c th\u1eed nghi\u1ec7m hi\u1ec7u l\u1ef1c kh\u1eed khu\u1ea9n theo ti\u00eau chu\u1ea9n k\u1ef9 thu\u1eadt.<\/p>\n<p><strong>Th\u1ef1c t\u1ebf t\u1eeb c\u00e1c c\u1ea3nh b\u00e1o c\u1ee7a FDA cho th\u1ea5y:<\/strong><\/p>\n<p>FDA ph\u00e1t hi\u1ec7n b\u1ec7nh vi\u1ec7n kh\u00f4ng \u00e1p d\u1ee5ng \u0111\u00fang contact time cho sporicide di\u1ec7t b\u00e0o t\u1eed d\u00f9ng trong t\u1ee7 an to\u00e0n sinh h\u1ecdc ISO 5:<\/p>\n<blockquote><p><em>&#8220;Did not adhere to minimum contact time for the sporicidal disinfectant used in the BSC and hot cell disinfection process.&#8221;<\/em><\/p>\n<p>\u2014 FDA Warning Letter, Brigham and Women&#8217;s Hospital Inc (04\/11\/2022)<\/p><\/blockquote>\n<p><strong>Link ngu\u1ed3n:<\/strong>\u00a0<a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/brigham-and-womens-hospital-inc-623476-04112022\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/brigham-and-womens-hospital-inc-623476-04112022<\/a><\/p>\n<p>FDA ghi nh\u1eadn m\u1ed9t c\u01a1 s\u1edf d\u01b0\u1ee3c compounding s\u1eed d\u1ee5ng contact time kh\u00f4ng \u0111\u1ee7 khi d\u00f9ng sporicide di\u1ec7t b\u00e0o t\u1eed trong ISO 5:<\/p>\n<blockquote><p><em>&#8220;The facility&#8217;s aseptic processing areas\u2026 did not ensure adequate contact time for the sporicidal agent.&#8221;<\/em><\/p>\n<p>\u2014 FDA Warning Letter, Greenpark Compounding Pharmacy (10\/26\/2018)<\/p><\/blockquote>\n<p><strong>Link ngu\u1ed3n:<\/strong>\u00a0<a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/greenpark-compounding-pharmacy-566233-10262018\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/greenpark-compounding-pharmacy-566233-10262018<\/a><\/p>\n<p><strong>\u0110i\u1ec3m h\u1ecdc \u0111\u01b0\u1ee3c:<\/strong>\u00a0Contact time kh\u00f4ng ph\u1ea3i l\u00e0 gi\u00e1 tr\u1ecb c\u00f3 th\u1ec3 t\u00f9y \u00fd l\u1ef1a ch\u1ecdn. N\u00f3 ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh r\u00f5 r\u00e0ng trong SOP d\u1ef1a tr\u00ean lo\u1ea1i sporicide di\u1ec7t b\u00e0o t\u1eed, n\u1ed3ng \u0111\u1ed9, nhi\u1ec7t \u0111\u1ed9 m\u00f4i tr\u01b0\u1eddng v\u00e0 lo\u1ea1i b\u1ec1 m\u1eb7p. N\u1ebfu SOP quy \u0111\u1ecbnh 15 ph\u00fat, th\u1eddi gian n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o hi\u1ec7u l\u1ef1c di\u1ec7t b\u00e0o t\u1eed.<\/p>\n<p><strong>Contact time ti\u00eau bi\u1ec3u cho c\u00e1c lo\u1ea1i sporicide ph\u1ed5 bi\u1ebfn:<\/strong><\/p>\n<ul>\n<li><strong>Hydrogen peroxide 7.5%<\/strong>\u00a0(STERIS, Contec, VAI\/Veltek, QT): 10-15 ph\u00fat<\/li>\n<li><strong>Hydrogen peroxide 35%<\/strong>: 3-10 ph\u00fat (n\u1ed3ng \u0111\u1ed9 cao h\u01a1n, t\u00e1c d\u1ee5ng nhanh h\u01a1n)<\/li>\n<li><strong>Peracetic acid 0.2-0.35%<\/strong>\u00a0(STERIS Spor-Klenz, Contec PeridoxRTU, VAI\/Veltek DECON-SPORE, QT Sporicide): 20-30 ph\u00fat<\/li>\n<li><strong>Glutaraldehyde 2-3.5%<\/strong>: 3-10 gi\u1edd (qu\u00e1 d\u00e0i cho kh\u1eed khu\u1ea9n h\u00e0ng ng\u00e0y)<\/li>\n<li><strong>Sodium Hypochlorite 0.52%-5.25%<\/strong>\u00a0(STERIS, VAI\/Veltek, Ecolab): 10-60 ph\u00fat (t\u00f9y t\u00e1c d\u1ee5ng mong mu\u1ed1n)<\/li>\n<\/ul>\n<h2><strong>Sporicide Di\u1ec7t B\u00e0o T\u1eed C\u00f3 Di\u1ec7t \u0110\u01b0\u1ee3c Vi Khu\u1ea9n, Virus, N\u1ea5m Kh\u00f4ng<\/strong><\/h2>\n<p>\u0110\u00e2y l\u00e0 m\u1ed9t c\u00e2u h\u1ecfi th\u01b0\u1eddng \u0111\u01b0\u1ee3c \u0111\u1eb7t ra v\u00ec c\u00f3 s\u1ef1 nh\u1ea7m l\u1eabn v\u1ec1 ph\u1ea1m vi t\u00e1c d\u1ee5ng c\u1ee7a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed.<\/p>\n<table>\n<thead>\n<tr>\n<th>Vi sinh v\u1eadt<\/th>\n<th>Sporicide di\u1ec7t b\u00e0o t\u1eed c\u00f3 di\u1ec7t kh\u00f4ng<\/th>\n<th>Gi\u1ea3i th\u00edch<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Vi khu\u1ea9n sinh d\u01b0\u1ee1ng<\/td>\n<td>C\u00f3<\/td>\n<td>Di\u1ec7t d\u1ec5 d\u00e0ng v\u00ec v\u1ecf t\u1ebf b\u00e0o m\u1ecfng<\/td>\n<\/tr>\n<tr>\n<td>B\u00e0o t\u1eed vi khu\u1ea9n<\/td>\n<td>C\u00f3<\/td>\n<td>\u0110\u00e2y l\u00e0 m\u1ee5c \u0111\u00edch ch\u00ednh c\u1ee7a sporicide<\/td>\n<\/tr>\n<tr>\n<td>Vi khu\u1ea9n g\u00e2y b\u1ec7nh (Staph, E. coli, Pseudomonas)<\/td>\n<td>C\u00f3<\/td>\n<td>T\u00f9y thu\u1ed9c v\u00e0o lo\u1ea1i sporicide, nh\u01b0ng h\u1ea7u h\u1ebft \u0111\u1ec1u di\u1ec7t \u0111\u01b0\u1ee3c<\/td>\n<\/tr>\n<tr>\n<td>Virus (enveloped)<\/td>\n<td>C\u00f3<\/td>\n<td>Sporicide m\u1ea1nh nh\u01b0 hydrogen peroxide c\u00f3 th\u1ec3 ph\u00e1 h\u1ee7y v\u1ecf virus<\/td>\n<\/tr>\n<tr>\n<td>Virus (non-enveloped)<\/td>\n<td>C\u00f3, nh\u01b0ng kh\u00f3 h\u01a1n<\/td>\n<td>Hi\u1ec7u l\u1ef1c ph\u1ee5 thu\u1ed9c v\u00e0o n\u1ed3ng \u0111\u1ed9 v\u00e0 contact time<\/td>\n<\/tr>\n<tr>\n<td>N\u1ea5m m\u1ed1c (hyphae)<\/td>\n<td>C\u00f3<\/td>\n<td>Sporicide di\u1ec7t \u0111\u01b0\u1ee3c c\u00e1c hyphae v\u00e0 b\u00e0o t\u1eed n\u1ea5m<\/td>\n<\/tr>\n<tr>\n<td>N\u1ea5m men (spore)<\/td>\n<td>C\u00f3<\/td>\n<td>Th\u01b0\u1eddng nh\u1ea1y c\u1ea3m v\u1edbi c\u00e1c ch\u1ea5t oxy h\u00f3a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Ngu\u1ed3n tham kh\u1ea3o:<\/strong>\u00a0<a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/pharmaceutic-labs-llc-492795-05032017\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/pharmaceutic-labs-llc-492795-05032017<\/a><\/p>\n<p><strong>Nh\u01b0ng c\u1ea7n l\u01b0u \u00fd:<\/strong>\u00a0Ph\u1ea1m vi di\u1ec7t r\u1ed9ng kh\u00f4ng c\u00f3 ngh\u0129a l\u00e0 sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 m\u1ed9t gi\u1ea3i ph\u00e1p to\u00e0n di\u1ec7n. M\u1ed7i lo\u1ea1i vi sinh v\u1eadt c\u00f3 c\u01a1 ch\u1ebf kh\u00e1ng kh\u00e1c nhau, do \u0111\u00f3:<\/p>\n<ul>\n<li>Virus non-enveloped (nh\u01b0 norovirus, rotavirus) c\u1ea7n contact time d\u00e0i h\u01a1n<\/li>\n<li>M\u1ed9t s\u1ed1 n\u1ea5m m\u1ed1c, \u0111\u1eb7c bi\u1ec7t l\u00e0\u00a0<em>Aspergillus<\/em>\u00a0v\u00e0\u00a0<em>Penicillium<\/em>, c\u00f3 kh\u1ea3 n\u0103ng kh\u00e1ng cao h\u01a1n vi khu\u1ea9n<\/li>\n<li>Prion (agent g\u00e2y b\u1ec7nh kh\u00f4ng c\u00f3 th\u00e0nh ph\u1ea7n di truy\u1ec1n chu\u1ea9n) kh\u00f4ng b\u1ecb di\u1ec7t b\u1edfi sporicide th\u00f4ng th\u01b0\u1eddng, c\u1ea7n kh\u1eed khu\u1ea9n \u0111\u1eb7c bi\u1ec7t<\/li>\n<\/ul>\n<h2><strong>Hydrogen Peroxide Sporicidal Di\u1ec7t B\u00e0o T\u1eed \u2014 Lo\u1ea1i \u0110\u01b0\u1ee3c \u01afu Ti\u00ean<\/strong><\/h2>\n<p>Trong c\u00e1c sporicidal disinfectants, hydrogen peroxide \u1edf d\u1ea3i n\u1ed3ng \u0111\u1ed9<strong> 7.5\u201335%<\/strong> th\u01b0\u1eddng \u0111\u01b0\u1ee3c \u01b0u ti\u00ean s\u1eed d\u1ee5ng trong ph\u00f2ng s\u1ea1ch GMP do c\u00e2n b\u1eb1ng t\u1ed1t gi\u1eefa hi\u1ec7u l\u1ef1c, an to\u00e0n v\u00e0 kh\u1ea3 n\u0103ng ph\u00e2n h\u1ee7y.<\/p>\n<p>Hydrogen peroxide di\u1ec7t b\u00e0o t\u1eed th\u00f4ng qua c\u01a1 ch\u1ebf oxy h\u00f3a m\u1ea1nh l\u00ean lipid m\u00e0ng, protein v\u00e0 v\u1eadt ch\u1ea5t di truy\u1ec1n, d\u1eabn \u0111\u1ebfn ph\u00e1 h\u1ee7y to\u00e0n b\u1ed9 c\u1ea5u tr\u00fac b\u1ea3o v\u1ec7 c\u1ee7a b\u00e0o t\u1eed.<\/p>\n<p><strong>\u01afu \u0111i\u1ec3m c\u1ee7a Hydrogen Peroxide &#8211; H\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed:<\/strong><\/p>\n<ul>\n<li>T\u00e1c d\u1ee5ng di\u1ec7t b\u00e0o t\u1eed m\u1ea1nh: Ph\u00e1 h\u1ee7y v\u1ecf b\u00e0o t\u1eed th\u00f4ng qua oxy h\u00f3a to\u00e0n b\u1ed9 c\u1ea5u tr\u00fac lipoprotein.<\/li>\n<li>Ph\u00e2n h\u1ee7y th\u00e0nh n\u01b0\u1edbc v\u00e0 oxy: Kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng \u0111\u1ed9c h\u1ea1i tr\u00ean b\u1ec1 m\u1eb7p \u2014 sau khi lau kh\u00f4, ch\u1ec9 c\u00f2n n\u01b0\u1edbc v\u00e0 oxy.<\/li>\n<li>Contact time ng\u1eafn: So v\u1edbi glutaraldehyde <strong>(3-10 gi\u1edd)<\/strong> ho\u1eb7c peracetic acid <strong>(20-30 ph\u00fat)<\/strong>, hydrogen peroxide ch\u1ec9 c\u1ea7n 10-15 ph\u00fat \u1edf n\u1ed3ng \u0111\u1ed9 7.5%.<\/li>\n<li>Ph\u1ed5 di\u1ec7t r\u1ed9ng: Di\u1ec7t \u0111\u01b0\u1ee3c vi khu\u1ea9n, n\u1ea5m m\u1ed1c, virus enveloped hi\u1ec7u qu\u1ea3.<\/li>\n<li>An to\u00e0n cho m\u00f4i tr\u01b0\u1eddng: Ph\u00e2n h\u1ee7y ho\u00e0n to\u00e0n th\u00e0nh n\u01b0\u1edbc v\u00e0 oxy, kh\u00f4ng g\u00e2y h\u1ea1i m\u00f4i tr\u01b0\u1eddng.<\/li>\n<\/ul>\n<p><strong>Nh\u01b0\u1ee3c \u0111i\u1ec3m c\u1ea7n l\u01b0u \u00fd:<\/strong><\/p>\n<ul>\n<li>\u0110\u1ed9 \u1ea9m trong kh\u00f4ng kh\u00ed c\u00f3 th\u1ec3 l\u00e0m gi\u1ea3m n\u1ed3ng \u0111\u1ed9 theo th\u1eddi gian, do \u0111\u00f3 c\u1ea7n b\u1ea3o qu\u1ea3n \u0111\u00fang \u0111i\u1ec1u ki\u1ec7n v\u00e0 ki\u1ec3m tra n\u1ed3ng \u0111\u1ed9 \u0111\u1ecbnh k\u1ef3.<\/li>\n<li>Kh\u00f4ng an to\u00e0n cho nh\u00e2n vi\u00ean \u1edf n\u1ed3ng \u0111\u1ed9 cao<strong> (35%)<\/strong> n\u1ebfu kh\u00f4ng c\u00f3 \u0111\u1ee7 b\u1ea3o v\u1ec7 c\u00e1 nh\u00e2n.<\/li>\n<li>T\u01b0\u01a1ng \u0111\u1ed1i \u0111\u1eaft h\u01a1n so v\u1edbi m\u1ed9t s\u1ed1 sporicide kh\u00e1c.<\/li>\n<\/ul>\n<p><strong>K\u1ef9 thu\u1eadt s\u1eed d\u1ee5ng Hydrogen Peroxide Sporicide Di\u1ec7t B\u00e0o T\u1eed:<\/strong><\/p>\n<ul>\n<li>Ki\u1ec3m tra n\u1ed3ng \u0111\u1ed9 tr\u01b0\u1edbc s\u1eed d\u1ee5ng b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng que th\u1eed ho\u1eb7c ph\u01b0\u01a1ng ph\u00e1p chu\u1ea9n \u0111\u1ed9 (Titration).<\/li>\n<li>X\u1ecbt ho\u1eb7c lau \u0111\u1ec1u tr\u00ean b\u1ec1 m\u1eb7p cho \u0111\u1ebfn \u01b0\u1edbt s\u00e2u.<\/li>\n<li>Duy tr\u00ec b\u1ec1 m\u1eb7p \u1ea9m (wet) trong su\u1ed1t contact time <strong>(10-15 ph\u00fat)<\/strong>.<\/li>\n<li>Sau contact time, lau s\u1ea1ch b\u1eb1ng n\u01b0\u1edbc c\u1ea5t ho\u1eb7c\u00a0<strong>70% isopropyl alcohol (nh\u01b0 QuantumTec 70 IPA ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m t\u01b0\u01a1ng t\u1ef1 c\u1ee7a STERIS, Contec, VAI\/Veltek)<\/strong>\u00a0\u0111\u1ec3 lo\u1ea1i b\u1ecf d\u01b0 l\u01b0\u1ee3ng.<\/li>\n<li>\u0110\u1ec3 b\u1ec1 m\u1eb7p kh\u00f4 t\u1ef1 nhi\u00ean ho\u1eb7c s\u1ea5y b\u1eb1ng kh\u00f4ng kh\u00ed s\u1ea1ch.<\/li>\n<\/ul>\n<h2>Sai L\u1ea7m Ph\u1ed5 Bi\u1ebfn Khi S\u1eed D\u1ee5ng Sporicide Di\u1ec7t B\u00e0o T\u1eed \u2014 B\u00e0i H\u1ecdc T\u1eeb FDA<\/h2>\n<p>M\u1ed9t trong nh\u1eefng sai l\u1ea7m ph\u1ed5 bi\u1ebfn nh\u1ea5t m\u00e0 FDA ghi nh\u1eadn l\u00e0 vi\u1ec7c kh\u00f4ng tu\u00e2n th\u1ee7 \u0111\u00fang contact time ho\u1eb7c kh\u00f4ng c\u00f3 k\u1ebf ho\u1ea1ch ki\u1ec3m so\u00e1t sporicide di\u1ec7t b\u00e0o t\u1eed to\u00e0n di\u1ec7n.<\/p>\n<p>C\u00f4ng ty Alexion (Soliris) b\u1ecb FDA ph\u00e1t hi\u1ec7n v\u1ea5n \u0111\u1ec1 ki\u1ec3m so\u00e1t b\u00e0o t\u1eed khi thanh tra ghi nh\u1eadn h\u1ecd t\u0103ng s\u1eed d\u1ee5ng sporicide di\u1ec7t b\u00e0o t\u1eed trong clean rooms nh\u01b0ng kh\u00f4ng x\u1eed l\u00fd \u0111\u01b0\u1ee3c nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 v\u1ea5n \u0111\u1ec1 v\u00e0 kh\u00f4ng x\u00e1c minh hi\u1ec7u qu\u1ea3 tr\u01b0\u1edbc khi ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t:<\/p>\n<blockquote><p><em>&#8220;Company increased the use of sporicidal agents in clean rooms but did not establish whether this action was effective or identify and resolve the root cause of the contamination issue.&#8221;<\/em><\/p>\n<p>\u2014 Fierce Pharma report on Alexion Soliris contamination<\/p><\/blockquote>\n<p><strong>Link ngu\u1ed3n:<\/strong>\u00a0<a href=\"https:\/\/www.fiercepharma.com\/drug-safety\/updated-warning-letter-details-contamination-of-alexion-s-soliris-api\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.fiercepharma.com\/drug-safety\/updated-warning-letter-details-contamination-of-alexion-s-soliris-api<\/a><\/p>\n<p><strong>B\u00e0i h\u1ecdc r\u00fat ra:<\/strong><\/p>\n<ul>\n<li><strong>S\u1eed d\u1ee5ng sporicide di\u1ec7t b\u00e0o t\u1eed kh\u00f4ng ph\u1ea3i l\u00e0 bi\u1ec7n ph\u00e1p ch\u1eefa ch\u00e1y<\/strong>\u00a0khi vi sinh t\u0103ng cao. C\u1ea7n ph\u1ea3i \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 tr\u01b0\u1edbc \u2014 \u0111\u00f3 c\u00f3 th\u1ec3 l\u00e0 do quy tr\u00ecnh v\u1ec7 sinh kh\u00f4ng \u0111\u1ea1t chu\u1ea9n, thi\u1ebft b\u1ecb b\u1ea3o tr\u00ec kh\u00f4ng s\u1ea1ch, ho\u1eb7c ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t vi sinh kh\u00f4ng nh\u1ea1y.<\/li>\n<li><strong>T\u0103ng t\u1ea7n su\u1ea5t ho\u1eb7c n\u1ed3ng \u0111\u1ed9 sporicide di\u1ec7t b\u00e0o t\u1eed m\u00e0 kh\u00f4ng c\u00f3 d\u1eef li\u1ec7u ch\u1ee9ng minh hi\u1ec7u qu\u1ea3 l\u00e0 vi ph\u1ea1m cGMP.<\/strong>\u00a0FDA y\u00eau c\u1ea7u c\u00e1c nh\u00e0 m\u00e1y ph\u1ea3i c\u00f3 b\u1eb1ng ch\u1ee9ng khoa h\u1ecdc (validation study) r\u1eb1ng k\u1ebf ho\u1ea1ch kh\u1eed khu\u1ea9n m\u1edbi th\u1ef1c s\u1ef1 c\u00f3 hi\u1ec7u qu\u1ea3 tr\u01b0\u1edbc khi \u00e1p d\u1ee5ng.<\/li>\n<li><strong>Ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n ph\u1ea3i \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf v\u1edbi logic r\u00f5 r\u00e0ng:<\/strong>\n<ul>\n<li>\u0110\u00e1nh gi\u00e1 r\u1ee7i ro vi sinh<\/li>\n<li>Ch\u1ecdn sporicide ph\u00f9 h\u1ee3p<\/li>\n<li>\u0110\u1ecbnh ngh\u0129a contact time<\/li>\n<li>Lu\u00e2n phi\u00ean h\u00f3a ch\u1ea5t<\/li>\n<li>Gi\u00e1m s\u00e1t k\u1ebft qu\u1ea3<\/li>\n<li>\u0110i\u1ec1u ch\u1ec9nh li\u00ean t\u1ee5c<\/li>\n<\/ul>\n<p>T\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c ghi ch\u00e9p v\u00e0 c\u00f3 b\u1eb1ng ch\u1ee9ng h\u1ed7 tr\u1ee3.<\/li>\n<\/ul>\n<h2>Chi\u1ebfn L\u01b0\u1ee3c T\u00edch H\u1ee3p Sporicide Di\u1ec7t B\u00e0o T\u1eed V\u00e0o Ch\u01b0\u01a1ng Tr\u00ecnh Ki\u1ec3m So\u00e1t Vi Sinh Ph\u00f2ng S\u1ea1ch<\/h2>\n<p>S\u1eed d\u1ee5ng sporicide di\u1ec7t b\u00e0o t\u1eed hi\u1ec7u qu\u1ea3 kh\u00f4ng ph\u1ea3i ch\u1ec9 l\u00e0 ch\u1ecdn \u0111\u00fang h\u00f3a ch\u1ea5t r\u1ed3i lau b\u1ec1 m\u1eb7p. C\u1ea7n c\u00f3 chi\u1ebfn l\u01b0\u1ee3c to\u00e0n di\u1ec7n.<\/p>\n<h3><strong>C\u00e1c b\u01b0\u1edbc thi\u1ebft l\u1eadp chi\u1ebfn l\u01b0\u1ee3c Sporicide Di\u1ec7t B\u00e0o T\u1eed:<\/strong><\/h3>\n<p><strong>B\u01b0\u1edbc 1: \u0110\u00e1nh gi\u00e1 r\u1ee7i ro vi sinh<\/strong><\/p>\n<p>Ph\u00e2n t\u00edch d\u1eef li\u1ec7u gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng t\u1eeb 3-6 th\u00e1ng tr\u01b0\u1edbc \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh lo\u1ea1i vi sinh v\u1eadt ch\u1ee7 y\u1ebfu (Bacillus, Clostridium, n\u1ea5m m\u1ed1c?), m\u1ee9c \u0111\u1ed9 nhi\u1ec5m b\u00ecnh th\u01b0\u1eddng v\u00e0 c\u00e1c \u0111i\u1ec3m n\u00f3ng (hot spots) c\u00f3 m\u1ee9c nhi\u1ec5m cao.<\/p>\n<p><strong>B\u01b0\u1edbc 2: L\u1ef1a ch\u1ecdn sporicide di\u1ec7t b\u00e0o t\u1eed d\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 r\u1ee7i ro<\/strong><\/p>\n<p>N\u1ebfu Bacillus cao, d\u00f9ng hydrogen peroxide. N\u1ebfu n\u1ea5m m\u1ed1c cao, d\u00f9ng peracetic acid ho\u1eb7c chlorine-based. \u0110\u1ecbnh ngh\u0129a r\u00f5 n\u1ed3ng \u0111\u1ed9 l\u00e0m vi\u1ec7c v\u00e0 contact time theo SOP.<\/p>\n<p><strong>B\u01b0\u1edbc 3: Thi\u1ebft l\u1eadp k\u1ebf ho\u1ea1ch lu\u00e2n phi\u00ean<\/strong><\/p>\n<p>X\u00e1c \u0111\u1ecbnh 2-3 lo\u1ea1i sporicide di\u1ec7t b\u00e0o t\u1eed kh\u00e1c nhau v\u00e0 chu k\u1ef3 lu\u00e2n phi\u00ean (v\u00ed d\u1ee5, tu\u1ea7n 1-2 l\u00e0 lo\u1ea1i A, tu\u1ea7n 3-4 l\u00e0 lo\u1ea1i B, r\u1ed3i quay l\u1ea1i lo\u1ea1i A). M\u1ee5c \u0111\u00edch l\u00e0 tr\u00e1nh vi khu\u1ea9n ph\u00e1t tri\u1ec3n kh\u00e1ng t\u00ednh.\u00a0<strong>L\u1ef1a ch\u1ecdn c\u00f3 th\u1ec3 bao g\u1ed3m c\u00e1c s\u1ea3n ph\u1ea9m t\u1eeb c\u00e1c h\u00e3ng kh\u00e1c nhau: QT Sporicide, STERIS Spor-Klenz, Contec PeridoxRTU, VAI\/Veltek DECON-SPORE, v.v.<\/strong><\/p>\n<p><strong>B\u01b0\u1edbc 4: \u0110\u00e0o t\u1ea1o v\u00e0 gi\u00e1m s\u00e1t nh\u00e2n s\u1ef1<\/strong><\/p>\n<p>\u0110\u1ea3m b\u1ea3o to\u00e0n b\u1ed9 nh\u00e2n vi\u00ean th\u1ef1c hi\u1ec7n kh\u1eed khu\u1ea9n hi\u1ec3u r\u00f5 t\u1ea1i sao c\u1ea7n sporicide di\u1ec7t b\u00e0o t\u1eed, lo\u1ea1i sporicide n\u00e0o, n\u1ed3ng \u0111\u1ed9 bao nhi\u00eau, contact time bao l\u00e2u, v\u00e0 c\u00e1ch ki\u1ec3m tra hi\u1ec7u qu\u1ea3.<\/p>\n<p><strong>B\u01b0\u1edbc 5: Gi\u00e1m s\u00e1t k\u1ebft qu\u1ea3 v\u00e0 \u0111i\u1ec1u ch\u1ec9nh<\/strong><\/p>\n<p>Ph\u00e2n t\u00edch d\u1eef li\u1ec7u m\u00f4i tr\u01b0\u1eddng h\u00e0ng th\u00e1ng sau khi \u00e1p d\u1ee5ng k\u1ebf ho\u1ea1ch sporicide di\u1ec7t b\u00e0o t\u1eed. N\u1ebfu m\u1ee9c Bacillus gi\u1ea3m v\u00e0 duy tr\u00ec \u1ed5n \u0111\u1ecbnh, k\u1ebf ho\u1ea1ch hi\u1ec7u qu\u1ea3. N\u1ebfu kh\u00f4ng, \u0111i\u1ec1u ch\u1ec9nh lo\u1ea1i sporicide, n\u1ed3ng \u0111\u1ed9, contact time, ho\u1eb7c t\u1ea7n su\u1ea5t.<\/p>\n<p>\u0110\u1ec3 t\u00ecm hi\u1ec3u th\u00eam v\u1ec1 c\u00e1ch thi\u1ebft l\u1eadp ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t vi sinh to\u00e0n di\u1ec7n v\u1edbi sporicide di\u1ec7t b\u00e0o t\u1eed nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a k\u1ebf ho\u1ea1ch kh\u1eed khu\u1ea9n, b\u1ea1n c\u00f3 th\u1ec3 tham kh\u1ea3o:\u00a0<strong><a href=\"https:\/\/sepro.vn\/kiem-soat-vi-sinh-tai-phong-sach\/\" target=\"_blank\" rel=\"noopener noreferrer\">Ki\u1ec3m So\u00e1t Vi Sinh T\u1ea1i Ph\u00f2ng S\u1ea1ch<\/a><\/strong><\/p>\n<h2>FAQ v\u1ec1 Sporicide Di\u1ec7t B\u00e0o T\u1eed<\/h2>\n<blockquote>\n<h3>Sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 g\u00ec?<\/h3>\n<p>Sporicide di\u1ec7t b\u00e0o t\u1eed, hay h\u00f3a ch\u1ea5t di\u1ec7t b\u00e0o t\u1eed, l\u00e0 t\u00e1c nh\u00e2n h\u00f3a h\u1ecdc c\u00f3 kh\u1ea3 n\u0103ng gi\u1ebft ch\u1ebft ho\u1eb7c v\u00f4 hi\u1ec7u h\u00f3a b\u00e0o t\u1eed vi khu\u1ea9n \u2014 nh\u1eefng d\u1ea1ng vi sinh v\u1eadt \u01b0a s\u1ed1ng trong \u0111i\u1ec1u ki\u1ec7n kh\u1eafc nghi\u1ec7t nh\u1ea5t.<\/p>\n<h3>H\u00f3a ch\u1ea5t n\u00e0o c\u00f3 t\u00e1c d\u1ee5ng di\u1ec7t b\u00e0o t\u1eed?<\/h3>\n<p>C\u00e1c h\u00f3a ch\u1ea5t ch\u00ednh bao g\u1ed3m hydrogen peroxide <strong>7.5%-35%<\/strong>, peracetic acid <strong>0.2-0.35%<\/strong>, glutaraldehyde <strong>2-3.5%<\/strong>, v\u00e0 sodium hypochlorite <strong>0.52%-5.25%<\/strong>.<\/p>\n<p><strong>Tr\u00ean th\u1ecb tr\u01b0\u1eddng, c\u00e1c nh\u00e3n hi\u1ec7u nh\u01b0 STERIS, Ecolab, Contec, VAI\/Veltek, Texwipe, v\u00e0 QT \u0111\u1ec1u cung c\u1ea5p c\u00e1c s\u1ea3n ph\u1ea9m di\u1ec7t b\u00e0o t\u1eed \u0111\u01b0\u1ee3c ch\u1ee9ng minh hi\u1ec7u l\u1ef1c. L\u1ef1a ch\u1ecdn n\u00ean d\u1ef1a tr\u00ean contact time, n\u1ed3ng \u0111\u1ed9, t\u01b0\u01a1ng th\u00edch b\u1ec1 m\u1eb7p v\u00e0 d\u1eef li\u1ec7u validation c\u1ee5 th\u1ec3, ch\u1ee9 kh\u00f4ng ch\u1ec9 t\u00ean brand. Hydrogen peroxide v\u00e0 peracetic acid v\u1eabn \u0111\u01b0\u1ee3c \u01b0u ti\u00ean v\u00ec hi\u1ec7u qu\u1ea3, an to\u00e0n v\u00e0 kh\u00f4ng \u0111\u1ec3 l\u1ea1i d\u01b0 l\u01b0\u1ee3ng \u0111\u1ed9c h\u1ea1i.<\/strong><\/p>\n<h3>Sporicide di\u1ec7t b\u00e0o t\u1eed kh\u00e1c g\u00ec kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng?<\/h3>\n<p>Kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng di\u1ec7t vi khu\u1ea9n sinh d\u01b0\u1ee1ng nhanh ch\u00f3ng nh\u01b0ng g\u1ea7n nh\u01b0 kh\u00f4ng t\u00e1c d\u1ee5ng tr\u00ean b\u00e0o t\u1eed. Sporicide di\u1ec7t b\u00e0o t\u1eed \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf ri\u00eang \u0111\u1ec3 xuy\u00ean th\u1ee7ng v\u1ecf b\u1ea3o v\u1ec7 c\u1ee9ng c\u1ee7a b\u00e0o t\u1eed v\u1edbi contact time t\u1eeb 10-60 ph\u00fat.<\/p>\n<h3>Contact time c\u1ee7a sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 bao l\u00e2u?<\/h3>\n<p>Contact time ph\u1ee5 thu\u1ed9c v\u00e0o lo\u1ea1i sporicide di\u1ec7t b\u00e0o t\u1eed v\u00e0 n\u1ed3ng \u0111\u1ed9. V\u00ed d\u1ee5: hydrogen peroxide <strong>7.5%<\/strong> c\u1ea7n <strong>10-15 ph\u00fat<\/strong>, peracetic acid <strong>0.2%<\/strong> c\u1ea7n <strong>20-30 ph\u00fat<\/strong>. Contact time ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a r\u00f5 r\u00e0ng trong SOP v\u00e0 tu\u00e2n th\u1ee7 ch\u1eb7t ch\u1ebd.<\/p>\n<h3>Khi n\u00e0o c\u1ea7n d\u00f9ng sporicide di\u1ec7t b\u00e0o t\u1eed?<\/h3>\n<p>Sporicide di\u1ec7t b\u00e0o t\u1eed c\u1ea7n \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ecbnh k\u1ef3 (h\u00e0ng tu\u1ea7n ho\u1eb7c hai tu\u1ea7n m\u1ed9t l\u1ea7n) trong ph\u00f2ng s\u1ea1ch GMP Grade A v\u00e0 B. Ngo\u00e0i ra, d\u00f9ng sau c\u00e1c s\u1ef1 ki\u1ec7n c\u00f3 nguy c\u01a1 cao (b\u1ea3o tr\u00ec, thay c\u1ea5u h\u00ecnh) ho\u1eb7c khi d\u1eef li\u1ec7u gi\u00e1m s\u00e1t vi sinh cho th\u1ea5y m\u1ee9c Bacillus t\u0103ng.<\/p>\n<h3>Sporicide di\u1ec7t b\u00e0o t\u1eed c\u00f3 di\u1ec7t \u0111\u01b0\u1ee3c virus v\u00e0 n\u1ea5m kh\u00f4ng?<\/h3>\n<p>C\u00f3. Sporicide di\u1ec7t b\u00e0o t\u1eed di\u1ec7t \u0111\u01b0\u1ee3c vi khu\u1ea9n sinh d\u01b0\u1ee1ng, b\u00e0o t\u1eed vi khu\u1ea9n, virus enveloped, n\u1ea5m m\u1ed1c v\u00e0 n\u1ea5m men. Tuy nhi\u00ean, virus non-enveloped (nh\u01b0 norovirus) c\u1ea7n contact time d\u00e0i h\u01a1n.<\/p><\/blockquote>\n<h2>K\u1ebft Lu\u1eadn<\/h2>\n<p>Sporicide di\u1ec7t b\u00e0o t\u1eed kh\u00f4ng ph\u1ea3i l\u00e0 m\u1ed9t c\u00f4ng c\u1ee5 ph\u1ee5 trong ch\u01b0\u01a1ng tr\u00ecnh v\u1ec7 sinh nh\u00e0 m\u00e1y d\u01b0\u1ee3c m\u00e0 l\u00e0 m\u1ed9t th\u00e0nh ph\u1ea7n kh\u00f4ng th\u1ec3 thi\u1ebfu c\u1ee7a b\u1ea5t k\u1ef3 h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t vi sinh n\u00e0o trong ph\u00f2ng s\u1ea1ch GMP. S\u1ef1 kh\u00e1c bi\u1ec7t gi\u1eefa m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n hi\u1ec7u qu\u1ea3 v\u00e0 m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u00f4ng \u0111\u1ea1t ti\u00eau chu\u1ea9n n\u1eb1m \u1edf vi\u1ec7c nh\u00e0 m\u00e1y hi\u1ec3u r\u00f5 t\u1ea1i sao sporicide di\u1ec7t b\u00e0o t\u1eed c\u1ea7n thi\u1ebft, khi n\u00e0o c\u1ea7n s\u1eed d\u1ee5ng, lo\u1ea1i n\u00e0o ph\u00f9 h\u1ee3p, contact time bao l\u00e2u v\u00e0 c\u00e1ch lu\u00e2n phi\u00ean \u0111\u1ec3 tr\u00e1nh kh\u00e1ng t\u00ednh.<\/p>\n<p>C\u00e1c c\u1ea3nh b\u00e1o c\u1ee7a FDA ghi nh\u1eadn r\u00f5 r\u00e0ng: kh\u00f4ng tu\u00e2n th\u1ee7 contact time ho\u1eb7c s\u1eed d\u1ee5ng sporicide di\u1ec7t b\u00e0o t\u1eed m\u00e0 kh\u00f4ng c\u00f3 k\u1ebf ho\u1ea1ch ki\u1ec3m so\u00e1t to\u00e0n di\u1ec7n l\u00e0 vi ph\u1ea1m cGMP nghi\u00eam tr\u1ecdng c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn s\u1ea3n ph\u1ea9m b\u1ecb \u00f4 nhi\u1ec5m v\u00e0 nguy hi\u1ec3m cho ng\u01b0\u1eddi b\u1ec7nh.<\/p>\n<p>N\u1ebfu b\u1ea1n \u0111ang x\u00e2y d\u1ef1ng ho\u1eb7c t\u1ed1i \u01b0u h\u00f3a ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n cho ph\u00f2ng s\u1ea1ch GMP c\u1ee7a m\u00ecnh, <strong><a href=\"https:\/\/sepro.vn\/\">Sepro<\/a> <\/strong>khuy\u00ean b\u1ea1n n\u00ean nh\u1edb r\u1eb1ng sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 m\u1ed9t ph\u1ea7n trong h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t ho\u00e0n ch\u1ec9nh \u2014 kh\u00f4ng ph\u1ea3i l\u00e0 gi\u1ea3i ph\u00e1p \u0111\u1ed9c l\u1eadp. K\u1ebft h\u1ee3p sporicide di\u1ec7t b\u00e0o t\u1eed v\u1edbi m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh gi\u00e1m s\u00e1t vi sinh m\u1ea1nh, SOP r\u00f5 r\u00e0ng, \u0111\u00e0o t\u1ea1o nh\u00e2n s\u1ef1 \u0111\u1ea7y \u0111\u1ee7, v\u00e0 \u0111i\u1ec1u ch\u1ec9nh li\u00ean t\u1ee5c d\u1ef1a tr\u00ean d\u1eef li\u1ec7u th\u1ef1c t\u1ebf l\u00e0 c\u00e1ch \u0111\u1ec3 x\u00e2y d\u1ef1ng m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh kh\u1eed khu\u1ea9n th\u1ef1c s\u1ef1 hi\u1ec7u qu\u1ea3.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Trong s\u1ea3n xu\u1ea5t d\u01b0\u1ee3c ph\u1ea9m v\u00e0 c\u00e1c m\u00f4i tr\u01b0\u1eddng ki\u1ec3m so\u00e1t nghi\u00eam ng\u1eb7t, sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 m\u1ed9t nh\u00f3m h\u00f3a ch\u1ea5t quan tr\u1ecdng trong vi\u1ec7c ki\u1ec3m so\u00e1t b\u00e0o t\u1eed nh\u01b0ng th\u01b0\u1eddng ch\u01b0a \u0111\u01b0\u1ee3c hi\u1ec3u \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 m\u1ee5c \u0111\u00edch v\u00e0 c\u00e1ch s\u1eed d\u1ee5ng. Kh\u00e1c v\u1edbi nhi\u1ec1u ch\u1ea5t kh\u1eed khu\u1ea9n th\u00f4ng th\u01b0\u1eddng ch\u1ec9 c\u00f3 t\u00e1c &hellip; <a href=\"https:\/\/sepro.vn\/vi\/sporicide-diet-bao-tu-la-gi-va-tai-sao-no-khong-the-thieu-trong-phong-sach-gmp\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Sporicide di\u1ec7t b\u00e0o t\u1eed l\u00e0 g\u00ec v\u00e0 t\u1ea1i sao n\u00f3 kh\u00f4ng th\u1ec3 thi\u1ebfu trong ph\u00f2ng s\u1ea1ch GMP<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":9447,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126],"tags":[],"class_list":["post-9431","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9431","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=9431"}],"version-history":[{"count":11,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9431\/revisions"}],"predecessor-version":[{"id":9460,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/9431\/revisions\/9460"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/9447"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=9431"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=9431"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=9431"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}