GMP Biological and Pharmaceutical Purifying Cleanroom

Service areas

biological and pharmaceutical products (oral agents, immune reagents, trauma supplies), pharmaceutical production (injection, tablet, capsule and drugs for external use only, traditional Chinese medicine), etc.

Purifying engineering imaging:

Biological pharmaceutical purification workshop

1. 1.         Operator purification

a)         Operator purification: biological medicine clean room (area) personnel purification program is as follows:

b)        Medicine clean zone shall be set up to the entrance of the gas chamber; The introduction of the gas chamber should be set interlock device.

c)         Air clean level the same sterile clean room and the sterile clean its personnel with room shall be installed separately purification.

1. 2.         material purification

a)         Medicine clean room raw and auxiliary materials, packaging material inward and outward, shall set up with material purification room.

b)        Into the sterile clean room raw materials, packaging material in addition to meeting the requirements above there should be set up in the entrance material room and the sterilization facilities.

c)         Material clean room or sterilization room and medicine clean room between shall set up gas chamber or pass ark.

1. 3.         100,000 grade and above area should be in clean indoor wash clothes, dry, whole shall, when necessary, according to requirements sterilization.

Air cleanliness  
class

The maximum allowable number of suspended  particles(pcs/ m² )

The maximum allowable number of suspended microorganisms

≥0.5um

≥5um

Plank tonic bacteria(cfu/m²)

Settling microbe(cfu/DISH)

100

3500

0

5

1

10000

350000

2000

100

3

100000

3500000

20000

500

10

Cleanliness level

DUST count/ m²

Microbial number/ m²

Ventilation  rate/h

≥0.5um

≥5um

10 000 Class

≤350 000

≤2 000

≤100

≥20 TIME

100 000Class

≤3500 000

≤20 000

≤500

≥15 TIME