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GMP and Clean Room

GMP and Clean Room

About GMP
GMP is the abbreviation of Good Manufacturing Practice, which is the mandatory requirements on the rationality of the production process, applicability of production equipment, and accuracy and normalization of the operations. The latest GMP (2010) was reviewed and approved by the Ministry of Health on October 19, 2010, and implemented since March 1, 2011.
GMP is the basic guidelines for pharmaceutical production and quality management, applicable for the whole production process of pharmaceutical preparations and the key processes that affect the finished product quality in the production of crude drugs. Vigorously promoting drug GMP is to avoid contamination and cross-contamination furthest in the process of drug production and reduce errors, and is an import measure to improve the drug quality.
At present, the drug produced in China and sold in the world should not only meet the GMP-2010 specifications but also the requirements of EU/GMP and FDA-cGMP.
GMP doesn’t list the requirements on the design, construction and testing of biological clean rooms in details. Please refer to GMP implementation guide, drug GMP compliance standard, FED 209E, ISO 14644, ISO 14698, IEST, GB/T, and EN1822.
Clean room and contamination control technology is one of the main approaches for successful

implementation of GMP.

Name Cleanliness grade Clean room test HEPA filter classification HEPA filter test
IES-RP-CC001.4 IEST-RP-CC006.3
ISO 14644-2&3
ISO 14698
EN 1822 EN1822
GMP-2011 FED 209 D&E
SO 14644-1
GB 50073-2001
GB/T 16292-2010
GB/T 16294-2010
GB/T 13554-2008 GB/T 6165-2008
Go with you on the road - make the air fresh
Air Cleanliness
The air clean area of biological clean room is divided into four sections:
Class A - High risk operation area, that is, affects the operation directly, such as: tunnel sterilizing oven, aseptic filling, bottle opening, and autoclave cooling zone need class-100 laminar flow. It affects the product quality directly and is called Class A.
Class B - The positions that affect the sterile operation area indirectly and surround Class A areas directly, such as aseptic filling room and autoclave cooling room.
Class C and D - Transitional clean area to enter sterile production area, such as preparation room, locker room and buffer room.
Cleanliness grade Maximum allowable number of particles/m Maximum allowable number of microorganisms Wind speed requirements m/s
≥0.5um ≥5um Planktonic bacteria/m3 Sedimentary bacteria/m3
Static/Dynamic Static/Dynamic Dynamic Dynamic
A (dynamic 100) 3.5x103/3.5x103 0/0 1 0.125 0.36-0.54
B (static 100) 3.5x103/3.5x103 0/2.0x103 10 0.625 -
C (10,000) 3.5x103/3.5x103 2.0x103/2.0x103 100 6.25 -
D (100,000) 3.5x103/------- 2.0x103/------ 200 12.5 -

General Comparison of Different Standards of Suspended Particles Classification in GMP

CN GMP-1998 CN GMP-2010 US FED 209D US FED 209E ISO14644-1 EU/GMP Annex 1 Recommend terminal filters
100(dynamic) A 100(dynamic) M3.5(dynamic) ISO5(static) A H14
100(static) B 100(static) M3.5(static) ISO5static) B H14
10000 C 10000 M5.5 ISO7 C H14
100000 D 100000 M6.5 ISO8 D H14
300000 - - M7 - - H11

Efficiency Comparison of Air Filters

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