{"id":8890,"date":"2026-02-09T08:43:48","date_gmt":"2026-02-09T08:43:48","guid":{"rendered":"https:\/\/sepro.vn\/?p=8890"},"modified":"2026-02-27T02:32:40","modified_gmt":"2026-02-27T02:32:40","slug":"thuat-ngu-pho-bien-trong-phong-sach-ban-can-biet","status":"publish","type":"post","link":"https:\/\/sepro.vn\/vi\/thuat-ngu-pho-bien-trong-phong-sach-ban-can-biet\/","title":{"rendered":"C\u00e1c Thu\u1eadt Ng\u1eef Ph\u00f2ng S\u1ea1ch B\u1ea1n C\u1ea7n \u0110\u01b0\u1ee3c Bi\u1ebft"},"content":{"rendered":"

Ph\u00f2ng s\u1ea1ch l\u00e0 n\u1ec1n t\u1ea3ng c\u1ee7a nhi\u1ec1u ng\u00e0nh c\u00f4ng nghi\u1ec7p nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, \u0111i\u1ec7n t\u1eed, b\u00e1n d\u1eabn, th\u1ef1c ph\u1ea9m v\u00e0 nghi\u00ean c\u1ee9u khoa h\u1ecdc. \u0110\u1ec3 thi\u1ebft k\u1ebf, thi c\u00f4ng ho\u1eb7c v\u1eadn h\u00e0nh \u0111\u00fang chu\u1ea9n, vi\u1ec7c hi\u1ec3u r\u00f5 thu\u1eadt ng\u1eef ph\u00f2ng s\u1ea1ch l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c. B\u00e0i vi\u1ebft n\u00e0y, Sepro<\/strong> t\u1ed5ng h\u1ee3p v\u00e0 h\u1ec7 th\u1ed1ng h\u00f3a thu\u1eadt ng\u1eef ph\u00f2ng s\u1ea1ch theo logic t\u1eeb ngo\u00e0i v\u00e0o trong theo ti\u00eau chu\u1ea9n GMP – EU Annex 1<\/a><\/em>, gi\u00fap ch\u00fang ta d\u1ec5 tra c\u1ee9u, d\u1ec5 ghi nh\u1edb.<\/p>\n

I. THU\u1eacT NG\u1eee KHU V\u1ef0C \u2013 KH\u00d4NG GIAN \u2013 D\u00d2NG DI CHUY\u1ec2N\u00a0<\/b><\/h2>\n

Nh\u00f3m thu\u1eadt ng\u1eef m\u00f4 t\u1ea3 c\u00e1ch t\u1ed5 ch\u1ee9c kh\u00f4ng gian, ph\u00e2n lu\u1ed3ng ng\u01b0\u1eddi v\u00e0 v\u1eadt li\u1ec7u trong ph\u00f2ng s\u1ea1ch. \u0110\u00e2y l\u00e0 l\u1edbp \u0111\u1ea7u ti\u00ean c\u1ea7n x\u00e1c \u0111\u1ecbnh \u0111\u1ec3 ki\u1ec3m so\u00e1t nhi\u1ec5m b\u1ea9n v\u00e0 tu\u00e2n th\u1ee7 y\u00eau c\u1ea7u GMP-EU.<\/p>\n

Airlock \u2013 Ph\u00f2ng kh\u00f3a kh\u00ed<\/b><\/h3>\n

Kh\u00f4ng gian trung gian gi\u1eefa hai khu v\u1ef1c c\u00f3 c\u1ea5p s\u1ea1ch kh\u00e1c nhau, gi\u00fap ki\u1ec3m so\u00e1t ch\u00eanh \u00e1p v\u00e0 h\u1ea1n ch\u1ebf kh\u00f4ng kh\u00ed b\u1ea9n x\u00e2m nh\u1eadp.<\/p>\n

Buffer Room \u2013 Ph\u00f2ng \u0111\u1ec7m<\/b><\/h3>\n

Ph\u00f2ng n\u1eb1m gi\u1eefa c\u00e1c ph\u00f2ng s\u1ea1ch ho\u1eb7c gi\u1eefa ph\u00f2ng s\u1ea1ch v\u00e0 m\u00f4i tr\u01b0\u1eddng b\u00ean ngo\u00e0i, d\u00f9ng \u0111\u1ec3 gi\u1ea3m nguy c\u01a1 nhi\u1ec5m ch\u00e9o.<\/p>\n

Air Shower \u2013 Ph\u00f2ng t\u1eafm kh\u00ed<\/b><\/h3>\n

Bu\u1ed3ng th\u1ed5i kh\u00ed t\u1ed1c \u0111\u1ed9 cao nh\u1eb1m lo\u1ea1i b\u1ecf b\u1ee5i b\u00e1m tr\u00ean qu\u1ea7n \u00e1o v\u00e0 c\u01a1 th\u1ec3 tr\u01b0\u1edbc khi v\u00e0o ph\u00f2ng s\u1ea1ch.<\/p>\n

Gowning Room \u2013 Ph\u00f2ng thay \u0111\u1ed3 ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n

Khu v\u1ef1c d\u00e0nh cho nh\u00e2n s\u1ef1 m\u1eb7c trang ph\u1ee5c ph\u00f2ng s\u1ea1ch theo quy tr\u00ecnh ki\u1ec3m so\u00e1t h\u1ea1t v\u00e0 vi sinh.<\/p>\n

Degowning Room \u2013 Ph\u00f2ng th\u00e1o \u0111\u1ed3 ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n

Khu v\u1ef1c th\u00e1o b\u1ecf \u0111\u1ed3 ph\u00f2ng s\u1ea1ch khi r\u1eddi kh\u1ecfi khu v\u1ef1c s\u1ea1ch nh\u1eb1m tr\u00e1nh ph\u00e1t t\u00e1n \u00f4 nhi\u1ec5m ra ngo\u00e0i.<\/p>\n

Cleanroom \u2013 Ph\u00f2ng s\u1ea1ch<\/a><\/strong><\/h3>\n

Kh\u00f4ng gian \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd v\u1ec1 h\u1ea1t b\u1ee5i, vi sinh, nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m v\u00e0 \u00e1p su\u1ea5t.<\/p>\n

Clean Zone \u2013 Khu v\u1ef1c s\u1ea1ch<\/b><\/h3>\n

C\u00e1c v\u00f9ng b\u00ean trong ph\u00f2ng s\u1ea1ch \u0111\u01b0\u1ee3c ph\u00e2n c\u1ea5p s\u1ea1ch kh\u00e1c nhau theo ISO ho\u1eb7c GMP.<\/p>\n

Material Flow \u2013 Lu\u1ed3ng v\u1eadt li\u1ec7u<\/b><\/h3>\n

H\u01b0\u1edbng di chuy\u1ec3n c\u1ee7a nguy\u00ean v\u1eadt li\u1ec7u trong ph\u00f2ng s\u1ea1ch nh\u1eb1m tr\u00e1nh nhi\u1ec5m ch\u00e9o.<\/p>\n

Personnel Flow \u2013 Lu\u1ed3ng nh\u00e2n s\u1ef1<\/b><\/h3>\n

Quy tr\u00ecnh di chuy\u1ec3n c\u1ee7a con ng\u01b0\u1eddi trong ph\u00f2ng s\u1ea1ch \u0111\u1ec3 gi\u1ea3m ph\u00e1t sinh h\u1ea1t v\u00e0 vi sinh.<\/p>\n

Contamination \u2013 Nhi\u1ec5m b\u1ea9n<\/b><\/h3>\n

S\u1ef1 xu\u1ea5t hi\u1ec7n c\u1ee7a h\u1ea1t b\u1ee5i, vi sinh ho\u1eb7c t\u1ea1p ch\u1ea5t kh\u00f4ng mong mu\u1ed1n trong ph\u00f2ng s\u1ea1ch.<\/p>\n

II. THU\u1eacT NG\u1eee C\u1ea4U TR\u00daC X\u00c2Y D\u1ef0NG \u2013 V\u1ece PH\u00d2NG S\u1ea0CH<\/b><\/h2>\n

C\u00e1c thu\u1eadt ng\u1eef li\u00ean quan \u0111\u1ebfn v\u1eadt li\u1ec7u, k\u1ebft c\u1ea5u v\u00e0 th\u00e0nh ph\u1ea7n x\u00e2y d\u1ef1ng t\u1ea1o n\u00ean kh\u00f4ng gian ph\u00f2ng s\u1ea1ch k\u00edn, d\u1ec5 v\u1ec7 sinh v\u00e0 duy tr\u00ec ch\u00eanh \u00e1p \u1ed5n \u0111\u1ecbnh.<\/p>\n

Cleanroom Partitions \u2013 V\u00e1ch ng\u0103n ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n

H\u1ec7 v\u00e1ch panel d\u00f9ng \u0111\u1ec3 ph\u00e2n chia c\u00e1c khu v\u1ef1c c\u00f3 c\u1ea5p s\u1ea1ch kh\u00e1c nhau.<\/p>\n

Panel \u2013 Panel Door \u2013 T\u1ea5m panel \/ C\u1eeda panel<\/b><\/h3>\n

V\u1eadt li\u1ec7u v\u00e0 c\u1eeda chuy\u00ean d\u1ee5ng cho ph\u00f2ng s\u1ea1ch, c\u00f3 b\u1ec1 m\u1eb7t nh\u1eb5n, k\u00edn kh\u00ed v\u00e0 d\u1ec5 v\u1ec7 sinh.<\/p>\n

Hermetic Door \u2013 C\u1eeda k\u00edn kh\u00ed<\/b><\/h3>\n

C\u1eeda c\u00f3 kh\u1ea3 n\u0103ng \u0111\u00f3ng k\u00edn ho\u00e0n to\u00e0n \u0111\u1ec3 duy tr\u00ec ch\u00eanh \u00e1p ph\u00f2ng s\u1ea1ch.<\/p>\n

Viewing Window \u2013 C\u1eeda s\u1ed5 quan s\u00e1t<\/b><\/h3>\n

C\u1eeda k\u00ednh hai l\u1edbp cho ph\u00e9p quan s\u00e1t b\u00ean trong ph\u00f2ng s\u1ea1ch m\u00e0 kh\u00f4ng c\u1ea7n ra v\u00e0o.<\/p>\n

Ceiling \u2013 Tr\u1ea7n ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n

H\u1ec7 tr\u1ea7n l\u1eafp \u0111\u1eb7t b\u1ed9 l\u1ecdc, \u0111\u00e8n v\u00e0 thi\u1ebft b\u1ecb ph\u00f2ng s\u1ea1ch.<\/p>\n

Ceiling Grid System \u2013 H\u1ec7 khung tr\u1ea7n<\/b><\/h3>\n

Khung k\u1ebft c\u1ea5u d\u00f9ng \u0111\u1ec3 c\u1ed1 \u0111\u1ecbnh panel tr\u1ea7n, \u0111\u00e8n v\u00e0 HEPA.<\/p>\n

Ceiling Coverage \u2013 T\u1ef7 l\u1ec7 ph\u1ee7 tr\u1ea7n<\/b><\/h3>\n

T\u1ef7 l\u1ec7 di\u1ec7n t\u00edch tr\u1ea7n \u0111\u01b0\u1ee3c l\u1eafp HEPA ho\u1eb7c thi\u1ebft b\u1ecb c\u1ea5p kh\u00ed.<\/p>\n

Coving \u2013 Bo g\u00f3c<\/b><\/h3>\n

Bo cong t\u1ea1i g\u00f3c t\u01b0\u1eddng \u2013 s\u00e0n ho\u1eb7c t\u01b0\u1eddng \u2013 tr\u1ea7n nh\u1eb1m tr\u00e1nh t\u00edch t\u1ee5 b\u1ee5i.<\/p>\n

Flooring System \u2013 H\u1ec7 s\u00e0n ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n

S\u00e0n vinyl, s\u00e0n n\u00e2ng ho\u1eb7c s\u00e0n deck \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u ch\u1ed1ng b\u1ee5i v\u00e0 ch\u1ed1ng t\u0129nh \u0111i\u1ec7n.<\/p>\n

Control Cabinet \u2013 T\u1ee7 \u0111i\u1ec1u khi\u1ec3n<\/b><\/h3>\n

T\u1ee7 ch\u1ee9a h\u1ec7 th\u1ed1ng \u0111i\u1ec1u khi\u1ec3n HVAC v\u00e0 c\u00e1c thi\u1ebft b\u1ecb k\u1ef9 thu\u1eadt.<\/p>\n

Electronic Cabinet \u2013 T\u1ee7 \u0111i\u1ec7n<\/b><\/h3>\n

T\u1ee7 ph\u00e2n ph\u1ed1i \u0111i\u1ec7n v\u00e0 b\u1ea3o v\u1ec7 thi\u1ebft b\u1ecb \u0111i\u1ec7n trong ph\u00f2ng s\u1ea1ch.<\/p>\n

III. THU\u1eacT NG\u1eee THI\u1ebeT B\u1eca & N\u1ed8I TH\u1ea4T PH\u00d2NG S\u1ea0CH<\/b><\/h2>\n

Nh\u00f3m thu\u1eadt ng\u1eef m\u00f4 t\u1ea3 b\u00e0n thao t\u00e1c, n\u1ed9i th\u1ea5t v\u00e0 thi\u1ebft b\u1ecb s\u1eed d\u1ee5ng tr\u1ef1c ti\u1ebfp b\u00ean trong ph\u00f2ng s\u1ea1ch, c\u00f3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn m\u1ee9c ph\u00e1t sinh h\u1ea1t v\u00e0 kh\u1ea3 n\u0103ng l\u00e0m s\u1ea1ch.<\/p>\n

Cleanroom Table \u2013 B\u00e0n ph\u00f2ng s\u1ea1ch<\/b><\/h3>\n

B\u00e0n l\u00e0m vi\u1ec7c b\u1eb1ng v\u1eadt li\u1ec7u kh\u00f4ng ph\u00e1t sinh h\u1ea1t.<\/p>\n

Cleanroom Suits \u2013 Trang ph\u1ee5c ph\u00f2ng s\u1ea1ch<\/a><\/strong><\/h3>\n

Qu\u1ea7n \u00e1o chuy\u00ean d\u1ee5ng gi\u00fap h\u1ea1n ch\u1ebf ph\u00e1t t\u00e1n h\u1ea1t v\u00e0 vi sinh t\u1eeb c\u01a1 th\u1ec3 ng\u01b0\u1eddi.<\/p>\n

Clean Booth \u2013 Ph\u00f2ng s\u1ea1ch c\u1ee1 nh\u1ecf<\/b><\/h3>\n

Ph\u00f2ng s\u1ea1ch \u0111\u1ed9c l\u1eadp ho\u1eb7c di \u0111\u1ed9ng d\u00f9ng cho khu v\u1ef1c c\u1ea7n \u0111\u1ed9 s\u1ea1ch cao c\u1ee5c b\u1ed9.<\/p>\n

Clean Bench \u2013 B\u00e0n thao t\u00e1c s\u1ea1ch<\/b><\/h3>\n

B\u00e0n l\u00e0m vi\u1ec7c c\u00f3 d\u00f2ng kh\u00ed m\u1ed9t chi\u1ec1u b\u1ea3o v\u1ec7 s\u1ea3n ph\u1ea9m kh\u1ecfi b\u1ee5i.<\/p>\n

IV. THU\u1eacT NG\u1eee H\u1ec6 TH\u1ed0NG KH\u00d4NG KH\u00cd \u2013 HVAC & D\u00d2NG KH\u00cd<\/b><\/h2>\n

C\u00e1c kh\u00e1i ni\u1ec7m c\u1ed1t l\u00f5i v\u1ec1 x\u1eed l\u00fd kh\u00f4ng kh\u00ed, l\u01b0u l\u01b0\u1ee3ng, h\u01b0\u1edbng d\u00f2ng kh\u00ed v\u00e0 ch\u00eanh \u00e1p, quy\u1ebft \u0111\u1ecbnh c\u1ea5p s\u1ea1ch v\u00e0 hi\u1ec7u su\u1ea5t v\u1eadn h\u00e0nh c\u1ee7a ph\u00f2ng s\u1ea1ch.<\/p>\n

HVAC \u2013 H\u1ec7 th\u1ed1ng s\u01b0\u1edfi, th\u00f4ng gi\u00f3 v\u00e0 \u0111i\u1ec1u h\u00f2a<\/b><\/h3>\n

H\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m, l\u01b0u l\u01b0\u1ee3ng v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng kh\u00f4ng kh\u00ed.<\/p>\n

AHU (Air Handling Unit) \u2013 Thi\u1ebft b\u1ecb x\u1eed l\u00fd kh\u00f4ng kh\u00ed<\/b><\/h3>\n

Thi\u1ebft b\u1ecb trung t\u00e2m l\u1ecdc v\u00e0 \u0111i\u1ec1u h\u00f2a kh\u00f4ng kh\u00ed c\u1ea5p v\u00e0o ph\u00f2ng s\u1ea1ch.<\/p>\n

FCU (Fan Coil Unit) \u2013 D\u00e0n l\u1ea1nh c\u1ee5c b\u1ed9<\/b><\/h3>\n

Thi\u1ebft b\u1ecb \u0111i\u1ec1u h\u00f2a nh\u1ecf g\u1ecdn, th\u01b0\u1eddng d\u00f9ng cho khu v\u1ef1c ph\u1ee5 tr\u1ee3.<\/p>\n

Chiller \/ Chilled Water \u2013 H\u1ec7 th\u1ed1ng n\u01b0\u1edbc l\u1ea1nh<\/b><\/h3>\n

H\u1ec7 th\u1ed1ng t\u1ea1o n\u01b0\u1edbc l\u1ea1nh cung c\u1ea5p cho AHU v\u00e0 FCU.<\/p>\n

Fresh Air \/ Exhaust Air \u2013 Gi\u00f3 t\u01b0\u01a1i \/ Gi\u00f3 th\u1ea3i<\/b><\/h3>\n

Kh\u00f4ng kh\u00ed c\u1ea5p m\u1edbi v\u00e0o v\u00e0 kh\u00f4ng kh\u00ed th\u1ea3i ra kh\u1ecfi ph\u00f2ng s\u1ea1ch.<\/p>\n

Air Flow Rate \u2013 L\u01b0u l\u01b0\u1ee3ng kh\u00f4ng kh\u00ed<\/b><\/h3>\n

L\u01b0\u1ee3ng kh\u00f4ng kh\u00ed \u0111\u01b0\u1ee3c c\u1ea5p ho\u1eb7c th\u1ea3i trong m\u1ed9t \u0111\u01a1n v\u1ecb th\u1eddi gian.<\/p>\n

Air Change Per Hour (ACH) \u2013 S\u1ed1 l\u1ea7n trao \u0111\u1ed5i kh\u00ed<\/b><\/h3>\n

S\u1ed1 l\u1ea7n kh\u00f4ng kh\u00ed trong ph\u00f2ng \u0111\u01b0\u1ee3c thay m\u1edbi trong m\u1ed9t gi\u1edd.<\/p>\n

Laminar Flow \u2013 D\u00f2ng kh\u00ed m\u1ed9t chi\u1ec1u<\/b><\/h3>\n

D\u00f2ng kh\u00ed chuy\u1ec3n \u0111\u1ed9ng song song, \u1ed5n \u0111\u1ecbnh v\u00e0 c\u00f3 h\u01b0\u1edbng x\u00e1c \u0111\u1ecbnh.<\/p>\n

Turbulent Flow \u2013 D\u00f2ng kh\u00ed h\u1ed7n lo\u1ea1n<\/b><\/h3>\n

D\u00f2ng kh\u00ed chuy\u1ec3n \u0111\u1ed9ng kh\u00f4ng \u0111\u1ecbnh h\u01b0\u1edbng, d\u00f9ng cho ph\u00f2ng di\u1ec7n r\u1ed9ng.<\/p>\n

Air Plenum \u2013 Khoang ph\u00e2n ph\u1ed1i kh\u00ed<\/b><\/h3>\n

Kho\u1ea3ng tr\u1ed1ng k\u1ef9 thu\u1eadt d\u00f9ng \u0111\u1ec3 ph\u00e2n ph\u1ed1i kh\u00ed \u0111\u1ec1u tr\u01b0\u1edbc khi v\u00e0o ph\u00f2ng.<\/p>\n

Pressure Differential \u2013 Ch\u00eanh \u00e1p<\/b><\/h3>\n

S\u1ef1 ch\u00eanh l\u1ec7ch \u00e1p su\u1ea5t gi\u1eefa c\u00e1c khu v\u1ef1c ph\u00f2ng s\u1ea1ch.<\/p>\n

Positive Pressure Room \u2013 Ph\u00f2ng \u00e1p d\u01b0\u01a1ng<\/b><\/h3>\n

Ph\u00f2ng c\u00f3 \u00e1p su\u1ea5t cao h\u01a1n khu v\u1ef1c xung quanh \u0111\u1ec3 ng\u0103n kh\u00ed b\u1ea9n x\u00e2m nh\u1eadp.<\/p>\n

Negative Pressure Room \u2013 Ph\u00f2ng \u00e1p \u00e2m<\/b><\/h3>\n

Ph\u00f2ng c\u00f3 \u00e1p su\u1ea5t th\u1ea5p h\u01a1n \u0111\u1ec3 gi\u1eef ch\u1ea5t \u00f4 nhi\u1ec5m b\u00ean trong.<\/p>\n

V. THU\u1eacT NG\u1eee H\u1ec6 TH\u1ed0NG L\u1eccC KH\u00cd \u2013 KI\u1ec2M SO\u00c1T H\u1ea0T<\/b><\/h2>\n

Nh\u00f3m thu\u1eadt ng\u1eef li\u00ean quan \u0111\u1ebfn b\u1ed9 l\u1ecdc, c\u1ea5p l\u1ecdc v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ph\u00e2n lo\u1ea1i \u2013 \u0111o ki\u1ec3m h\u1ea1t trong kh\u00f4ng kh\u00ed theo ti\u00eau chu\u1ea9n ISO v\u00e0 GMP.<\/p>\n

HEPA Filter \u2013 B\u1ed9 l\u1ecdc hi\u1ec7u su\u1ea5t cao<\/b><\/h3>\n

B\u1ed9 l\u1ecdc lo\u1ea1i b\u1ecf ph\u1ea7n l\u1edbn h\u1ea1t b\u1ee5i k\u00edch th\u01b0\u1edbc nh\u1ecf trong kh\u00f4ng kh\u00ed.<\/p>\n

Filter Module \u2013 Module l\u1ecdc kh\u00ed<\/b><\/h3>\n

C\u1ee5m thi\u1ebft b\u1ecb t\u00edch h\u1ee3p qu\u1ea1t v\u00e0 b\u1ed9 l\u1ecdc.<\/p>\n

ULPA Filter \u2013 B\u1ed9 l\u1ecdc si\u00eau m\u1ecbn<\/b><\/h3>\n

B\u1ed9 l\u1ecdc c\u00f3 hi\u1ec7u su\u1ea5t cao h\u01a1n HEPA, d\u00f9ng cho ph\u00f2ng si\u00eau s\u1ea1ch.<\/p>\n

Pre-filter \/ Medium Filter \/ Fine Filter \u2013 L\u1ecdc th\u00f4 \/ trung gian \/ tinh<\/b><\/h3>\n

C\u00e1c c\u1ea5p l\u1ecdc b\u1ea3o v\u1ec7 HEPA v\u00e0 k\u00e9o d\u00e0i tu\u1ed5i th\u1ecd h\u1ec7 th\u1ed1ng.<\/p>\n

Airborne Particulate Cleanliness Class Number \u2013 C\u1ea5p s\u1ea1ch theo h\u1ea1t<\/b><\/h3>\n

Ch\u1ec9 s\u1ed1 ph\u00e2n lo\u1ea1i \u0111\u1ed9 s\u1ea1ch d\u1ef1a tr\u00ean m\u1eadt \u0111\u1ed9 h\u1ea1t trong kh\u00f4ng kh\u00ed.<\/p>\n

Particle Count \u2013 \u0110\u1ebfm h\u1ea1t<\/b><\/h3>\n

Ho\u1ea1t \u0111\u1ed9ng \u0111o s\u1ed1 l\u01b0\u1ee3ng h\u1ea1t trong ph\u00f2ng s\u1ea1ch.<\/p>\n

Particle Counter \u2013 Thi\u1ebft b\u1ecb \u0111\u1ebfm h\u1ea1t<\/b><\/h3>\n

Thi\u1ebft b\u1ecb d\u00f9ng \u0111\u1ec3 \u0111o v\u00e0 ghi nh\u1eadn m\u1eadt \u0111\u1ed9 h\u1ea1t b\u1ee5i.<\/p>\n

VI. THU\u1eacT NG\u1eee CHUY\u1ec2N GIAO V\u1eacT T\u01af & PH\u1ee4 TR\u1ee2<\/b><\/h2>\n

C\u00e1c thu\u1eadt ng\u1eef d\u00f9ng cho vi\u1ec7c trung chuy\u1ec3n v\u1eadt t\u01b0 v\u00e0o ph\u00f2ng s\u1ea1ch m\u00e0 kh\u00f4ng l\u00e0m \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u1ea5p s\u1ea1ch v\u00e0 ch\u00eanh \u00e1p.<\/p>\n

Cleanroom Pass Thru \u2013 H\u00e0nh lang \/ h\u1ed9p trung chuy\u1ec3n<\/b><\/h3>\n

Khu v\u1ef1c ho\u1eb7c thi\u1ebft b\u1ecb cho ph\u00e9p chuy\u1ec3n v\u1eadt li\u1ec7u qua ph\u00f2ng s\u1ea1ch.<\/p>\n

Pass Box \u2013 H\u1ed9p chuy\u1ec3n \u0111\u1ed3<\/b><\/h3>\n

Thi\u1ebft b\u1ecb trung chuy\u1ec3n v\u1eadt t\u01b0 gi\u1eefa c\u00e1c khu v\u1ef1c c\u00f3 c\u1ea5p s\u1ea1ch kh\u00e1c nhau.<\/p>\n

Dynamic Pass Box \u2013 Pass box c\u00f3 th\u1ed5i kh\u00ed<\/b><\/h3>\n

Pass box t\u00edch h\u1ee3p h\u1ec7 th\u1ed1ng l\u1ecdc v\u00e0 c\u1ea5p kh\u00ed.<\/p>\n

Static Pass Box \u2013 Pass box t\u0129nh<\/b><\/h3>\n

Pass box kh\u00f4ng c\u00f3 h\u1ec7 th\u1ed1ng kh\u00ed.<\/p>\n

Interlock System \u2013 H\u1ec7 th\u1ed1ng li\u00ean \u0111\u1ed9ng<\/b><\/h3>\n

C\u01a1 ch\u1ebf kh\u00f3a li\u00ean \u0111\u1ed9ng ng\u0103n m\u1edf \u0111\u1ed3ng th\u1eddi hai c\u1eeda.<\/p>\n

VII. THU\u1eacT NG\u1eee TR\u1ea0NG TH\u00c1I V\u1eacN H\u00c0NH & HI\u1ec6U SU\u1ea4T<\/b><\/h2>\n

Nh\u00f3m thu\u1eadt ng\u1eef d\u00f9ng \u0111\u1ec3 m\u00f4 t\u1ea3 c\u00e1c tr\u1ea1ng th\u00e1i ho\u1ea1t \u0111\u1ed9ng c\u1ee7a ph\u00f2ng s\u1ea1ch v\u00e0 \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng ph\u1ee5c h\u1ed3i m\u00f4i tr\u01b0\u1eddng sau nhi\u1ec5u lo\u1ea1n.<\/p>\n

As-built \u2013 Tr\u1ea1ng th\u00e1i ho\u00e0n thi\u1ec7n x\u00e2y d\u1ef1ng<\/b><\/h3>\n

Ph\u00f2ng s\u1ea1ch sau khi x\u00e2y xong, ch\u01b0a l\u1eafp thi\u1ebft b\u1ecb v\u00e0 ch\u01b0a v\u1eadn h\u00e0nh.<\/p>\n

At-rest \u2013 Tr\u1ea1ng th\u00e1i ngh\u1ec9<\/b><\/h3>\n

Ph\u00f2ng s\u1ea1ch c\u00f3 \u0111\u1ea7y \u0111\u1ee7 thi\u1ebft b\u1ecb nh\u01b0ng kh\u00f4ng c\u00f3 nh\u00e2n s\u1ef1.<\/p>\n

Operational \u2013 Tr\u1ea1ng th\u00e1i v\u1eadn h\u00e0nh<\/b><\/h3>\n

Ph\u00f2ng s\u1ea1ch ho\u1ea1t \u0111\u1ed9ng v\u1edbi \u0111\u1ea7y \u0111\u1ee7 ng\u01b0\u1eddi v\u00e0 thi\u1ebft b\u1ecb.<\/p>\n

Room Recovery Rate \u2013 Th\u1eddi gian ph\u1ee5c h\u1ed3i s\u1ea1ch<\/b><\/h3>\n

Th\u1eddi gian ph\u00f2ng tr\u1edf v\u1ec1 m\u1ee9c s\u1ea1ch ban \u0111\u1ea7u sau nhi\u1ec5u lo\u1ea1n.<\/p>\n

VIII. THU\u1eacT NG\u1eee KI\u1ec2M SO\u00c1T VI SINH \u2013 AN TO\u00c0N \u2013 M\u00d4I TR\u01af\u1edcNG<\/b><\/a><\/h2>\n

C\u00e1c thu\u1eadt ng\u1eef li\u00ean quan \u0111\u1ebfn vi sinh, t\u0129nh \u0111i\u1ec7n v\u00e0 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng, \u0111\u1eb7c bi\u1ec7t quan tr\u1ecdng trong d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

Electrostatic Discharge (ESD) \u2013 Ph\u00f3ng t\u0129nh \u0111i\u1ec7n<\/b><\/h3>\n

Hi\u1ec7n t\u01b0\u1ee3ng t\u00edch t\u1ee5 v\u00e0 ph\u00f3ng \u0111i\u1ec7n g\u00e2y h\u1ea1i cho linh ki\u1ec7n \u0111i\u1ec7n t\u1eed.<\/p>\n

Viable Particles \u2013 H\u1ea1t s\u1ed1ng<\/b><\/h3>\n

H\u1ea1t mang vi sinh v\u1eadt c\u00f3 kh\u1ea3 n\u0103ng sinh tr\u01b0\u1edfng.<\/p>\n

Non-viable Particles \u2013 H\u1ea1t kh\u00f4ng s\u1ed1ng<\/b><\/h3>\n

H\u1ea1t b\u1ee5i kh\u00f4ng mang vi sinh.<\/p>\n

CFU (Colony Forming Unit) \u2013 \u0110\u01a1n v\u1ecb h\u00ecnh th\u00e0nh khu\u1ea9n l\u1ea1c<\/b><\/h3>\n

\u0110\u01a1n v\u1ecb \u0111o vi sinh trong gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng.<\/p>\n

Bioburden \u2013 T\u1ea3i l\u01b0\u1ee3ng vi sinh<\/b><\/h3>\n

T\u1ed5ng s\u1ed1 vi sinh v\u1eadt hi\u1ec7n di\u1ec7n tr\u00ean b\u1ec1 m\u1eb7t ho\u1eb7c trong m\u00f4i tr\u01b0\u1eddng.<\/p>\n

Environmental Monitoring (EM) \u2013 Gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng<\/b><\/h3>\n

Ho\u1ea1t \u0111\u1ed9ng theo d\u00f5i h\u1ea1t, vi sinh v\u00e0 \u0111i\u1ec1u ki\u1ec7n m\u00f4i tr\u01b0\u1eddng ph\u00f2ng s\u1ea1ch.<\/p>\n

IX. THU\u1eacT NG\u1eee KI\u1ec2M TH\u1eec \u2013 TH\u1ea8M \u0110\u1ecaNH \u2013 CH\u1ee8NG NH\u1eacN<\/b><\/h2>\n

Nh\u00f3m thu\u1eadt ng\u1eef d\u00f9ng trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra, th\u1ea9m \u0111\u1ecbnh v\u00e0 ch\u1ee9ng nh\u1eadn ph\u00f2ng s\u1ea1ch nh\u1eb1m ch\u1ee9ng minh s\u1ef1 tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n k\u1ef9 thu\u1eadt.<\/p>\n

DOP \/ PAO Test \u2013 Th\u1eed r\u00f2 r\u1ec9 HEPA<\/b><\/h3>\n

Ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra \u0111\u1ed9 k\u00edn c\u1ee7a b\u1ed9 l\u1ecdc HEPA.<\/p>\n

Airflow Visualization (Smoke Test) \u2013 Ki\u1ec3m tra h\u01b0\u1edbng d\u00f2ng kh\u00ed<\/b><\/h3>\n

Th\u1eed nghi\u1ec7m b\u1eb1ng kh\u00f3i \u0111\u1ec3 quan s\u00e1t d\u00f2ng kh\u00ed.<\/p>\n

IQ (Installation Qualification) \u2013 Th\u1ea9m \u0111\u1ecbnh l\u1eafp \u0111\u1eb7t<\/b><\/h3>\n

X\u00e1c nh\u1eadn h\u1ec7 th\u1ed1ng \u0111\u01b0\u1ee3c l\u1eafp \u0111\u1eb7t \u0111\u00fang thi\u1ebft k\u1ebf.<\/p>\n

OQ (Operational Qualification) \u2013 Th\u1ea9m \u0111\u1ecbnh v\u1eadn h\u00e0nh<\/b><\/h3>\n

X\u00e1c nh\u1eadn h\u1ec7 th\u1ed1ng v\u1eadn h\u00e0nh \u0111\u00fang th\u00f4ng s\u1ed1.<\/p>\n

PQ (Performance Qualification) \u2013 Th\u1ea9m \u0111\u1ecbnh hi\u1ec7u su\u1ea5t<\/b><\/h3>\n

X\u00e1c nh\u1eadn ph\u00f2ng s\u1ea1ch \u0111\u1ea1t hi\u1ec7u su\u1ea5t y\u00eau c\u1ea7u trong th\u1ef1c t\u1ebf.<\/p>\n

K\u1ebft lu\u1eadn<\/strong><\/h2>\n

Vi\u1ec7c n\u1eafm r\u00f5 c\u00e1c thu\u1eadt ng\u1eef ph\u00f2ng s\u1ea1ch gi\u00fap doanh nghi\u1ec7p v\u00e0 \u0111\u1ed9i ng\u0169 k\u1ef9 thu\u1eadt hi\u1ec3u \u0111\u00fang y\u00eau c\u1ea7u thi\u1ebft k\u1ebf, v\u1eadn h\u00e0nh v\u00e0 ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng theo ti\u00eau chu\u1ea9n ISO v\u00e0 GMP. Khi c\u00e1c kh\u00e1i ni\u1ec7m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng th\u1ed1ng nh\u1ea5t, qu\u00e1 tr\u00ecnh trao \u0111\u1ed5i k\u1ef9 thu\u1eadt, tri\u1ec3n khai d\u1ef1 \u00e1n v\u00e0 \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng ph\u00f2ng s\u1ea1ch s\u1ebd ch\u00ednh x\u00e1c v\u00e0 hi\u1ec7u qu\u1ea3 h\u01a1n.<\/p>\n

SEPRO<\/a> cung c\u1ea5p gi\u1ea3i ph\u00e1p ph\u00f2ng s\u1ea1ch to\u00e0n di\u1ec7n, h\u1ed7 tr\u1ee3 t\u1eeb t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt, thi\u1ebft k\u1ebf \u0111\u1ebfn thi c\u00f4ng v\u00e0 ki\u1ec3m \u0111\u1ecbnh, \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u kh\u1eaft khe c\u1ee7a nhi\u1ec1u l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t v\u00e0 nghi\u00ean c\u1ee9u.<\/p>\n

FAQ \u2013 C\u00e2u H\u1ecfi Th\u01b0\u1eddng G\u1eb7p<\/strong><\/h1>\n

ISO Class v\u00e0 GMP Grade kh\u00e1c nhau nh\u01b0 th\u1ebf n\u00e0o?<\/h3>\n

ISO t\u1eadp trung v\u00e0o h\u1ea1t; GMP t\u1eadp trung th\u00eam v\u00e0o vi sinh v\u00e0 quy tr\u00ecnh.<\/p>\n

Air Shower c\u00f3 b\u1eaft bu\u1ed9c kh\u00f4ng?<\/h3>\n

\u0110i\u1ec7n t\u1eed th\u01b0\u1eddng y\u00eau c\u1ea7u; GMP th\u00ec kh\u00f4ng b\u1eaft bu\u1ed9c nh\u01b0ng y\u00eau c\u1ea7u gowning nghi\u00eam ng\u1eb7t.<\/p>\n

Ch\u00eanh \u00e1p bao nhi\u00eau l\u00e0 \u0111\u1ea1t chu\u1ea9n?<\/h3>\n

10\u201315 Pa gi\u1eefa hai ph\u00f2ng li\u1ec1n k\u1ec1 c\u00f3 c\u1ea5p s\u1ea1ch kh\u00e1c nhau.<\/p>\n

HEPA bao l\u00e2u ph\u1ea3i thay?<\/h3>\n

6\u201312 th\u00e1ng t\u00f9y t\u1ea3i, theo k\u1ebft qu\u1ea3 PAO test v\u00e0 ch\u00eanh \u00e1p.<\/p>\n

Airlock v\u00e0 Buffer Room c\u00f3 gi\u1ed1ng nhau kh\u00f4ng?<\/h3>\n

Kh\u00f4ng ho\u00e0n to\u00e0n. Airlock t\u1eadp trung ki\u1ec3m so\u00e1t ch\u00eanh \u00e1p khi ra v\u00e0o, trong khi Buffer Room \u0111\u00f3ng vai tr\u00f2 v\u00f9ng \u0111\u1ec7m gi\u1eefa c\u00e1c khu v\u1ef1c.<\/p>\n

T\u1ea1i sao ph\u1ea3i ph\u00e2n lu\u1ed3ng ng\u01b0\u1eddi v\u00e0 v\u1eadt li\u1ec7u trong ph\u00f2ng s\u1ea1ch?<\/h3>\n

\u0110\u1ec3 h\u1ea1n ch\u1ebf nhi\u1ec5m ch\u00e9o, gi\u1ea3m ph\u00e1t sinh h\u1ea1t v\u00e0 \u0111\u1ea3m b\u1ea3o \u0111i\u1ec1u ki\u1ec7n s\u1ea1ch \u1ed5n \u0111\u1ecbnh.<\/p>\n","protected":false},"excerpt":{"rendered":"

Ph\u00f2ng s\u1ea1ch l\u00e0 n\u1ec1n t\u1ea3ng c\u1ee7a nhi\u1ec1u ng\u00e0nh c\u00f4ng nghi\u1ec7p nh\u01b0 d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf, \u0111i\u1ec7n t\u1eed, b\u00e1n d\u1eabn, th\u1ef1c ph\u1ea9m v\u00e0 nghi\u00ean c\u1ee9u khoa h\u1ecdc. \u0110\u1ec3 thi\u1ebft k\u1ebf, thi c\u00f4ng ho\u1eb7c v\u1eadn h\u00e0nh \u0111\u00fang chu\u1ea9n, vi\u1ec7c hi\u1ec3u r\u00f5 thu\u1eadt ng\u1eef ph\u00f2ng s\u1ea1ch l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c. B\u00e0i vi\u1ebft n\u00e0y, Sepro t\u1ed5ng … Continue reading C\u00e1c Thu\u1eadt Ng\u1eef Ph\u00f2ng S\u1ea1ch B\u1ea1n C\u1ea7n \u0110\u01b0\u1ee3c Bi\u1ebft<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":8906,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[126,42],"tags":[176,178,170,173,174,183,172,177,181,180,179,171,182,175],"class_list":["post-8890","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc","category-uncategorized-vi","tag-ach","tag-airlock-phong-sach","tag-cleanroom","tag-gmp","tag-hepa","tag-hvac-phong-sach-vi","tag-iso-14644","tag-laminar-flow","tag-phong-sach-vi","tag-thi-cong-phong-sach","tag-thiet-ke-phong-sach","tag-thuat-ngu-phong-sach","tag-tieu-chuan-phong-sach-vi","tag-ulpa"],"acf":[],"_links":{"self":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/8890","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/comments?post=8890"}],"version-history":[{"count":6,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/8890\/revisions"}],"predecessor-version":[{"id":8911,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/posts\/8890\/revisions\/8911"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media\/8906"}],"wp:attachment":[{"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/media?parent=8890"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/categories?post=8890"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sepro.vn\/vi\/wp-json\/wp\/v2\/tags?post=8890"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}