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PIC/S Regulations

Area

Area Description

Class A

Local areas involved high-risk tasks such as filling area, rubber stopper storage pot, opened ampoules and vials, and making aseptic connections. Such conditions are basically provided by laminar flow station/bench. In working locations involved open clean room application, laminar airflow system shall provide even airflow speed of 0.36 to 0.54 M/Sec (guideline value).
Laminarity shall be kept at uni-directional airflow, and lower speed is allowed to be used in closed insulation device and glove boxes.

Class B

For aseptic preparation and filling, this is the background environment for A class areas.

Class C
and D

Works in clean areas involved relatively non-crucial stages during manufacturing aseptic products.
PIC/S GMP ANNEX1 GENERAL
 

Static

Dynamic

Class

Maximum Allowance of Equal to or More than Particle No. listed below in M3
  0.5μm 5μm 0.5μm 5μm

A

3,520 20 3,520 20

B

3,520 29 352,000 2,900

C

352,000 2,900 3,520,000 29,000

D

3,520,000 29,000 Not defined Not defined

Based on Global GMP Standard Compliant Forum - 14th July 2010 – Modular GMP Cleanroom Design & ISO 14644

Recommended Limits for Surveillance of Microorganisms in Dynamic Clean Areas(a)
Recommended Limits for Microorganisms Contamination(a)

Class

Air Sample
cfu/m3

Settle Plate
(90mm diameter),
at cfu/4(b)

Contact Plate
(55mm diameter),
cfu/culture plate

Glove Print
Print 5 fingers/glove
cfu/glove

A

<1 <1 <1 <1

B

10 5 5 5

C

100 50 25 -

D

200 100 50 -
Remarks:  (a) All are average values.
 (b) Exposure time for individual settle plates may be less than 4 hours.
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