Cleanroom sedimentation bacteria detection standard operating procedures

Cleanroom sedimentation bacteria detection

Standard Operating Procedures

Document No.

ZL/SOP/ZK/02200

Edition

First Edition

1. Purpose

To establish a standard operating procedure for sedimentation detection to standardize the Detection operation of employees.

2. Scope

Applicable to the detection of sedimentation bacteria in the company's internal production clean area.

3. Responsibility

The production department, production workshop, quality management department, QC inspection room director, and inspectors are responsible for the implementation of this procedure.

4. Testing Basis

YY/T0188.6-1995 Drug Inspection Operation Procedure, Part 6, Drug Bioassay.

5. Content

5.1 Equipment

High Pressure Sterilizer

Used for sterilization of equipment

Constant Temperature Incubator

For culturing samples

5.2 Culture Medium and Plate Preparation

Culture dish: Generally use 490mmx15mm borosilicate glass culture dish
Culture medium: Generally uses ordinary broth agar culture medium or other culture medium approved by the pharmacopoeia
Place the culture dish in 121℃ wet heat sterilization for 20 minutes or dry heat sterilization at 180℃ for 2 hours
Heat the culture medium to melt, and when it cools to 45℃, inject the culture medium into the culture dish under the requirements of sterile operation, about 15ml per dish
After the agar is dissolved, invert the culture medium plane in a constant temperature incubator at 30~35℃ for 48 hours
The prepared culture medium plane should be stored in an environment of 2~8℃

5.3 Sampling Points

The arrangement of sampling points should be uniform to avoid excessive concentration in a certain local area
According to the size of the clean area, the minimum number of sampling points should be formulated
The location of the sampling point in the working area is about 0.8m~1.5m from the ground
Add sampling points at key equipment or key work activity range

Test Standards

Static Standards for Clean Area Microbial monitoring

Level	sedimentation bacteria (90mm) cfu/0.5hour	Frequency
100 level	≤1	1 time/month
10000 level	≤3	1 time/month
100000 level	≤10	1 time/month

Dynamic Standards for Clean Area Microbial monitoring

Level	Sedimentation Bacteria (90mm) cfu/0.5hour	Frequency	Surface Microorganisms Contact Plate (55mm) cfu/plate	5-finger Gloves cfu/gloves	Frequency
100 level	≤1	1 time/day	<1	<1	1 time/shift
10000 level	≤3	1 time/day	-	-	-
100000 level	≤10	1 time/week	-	-	-

5.4 Test Rules

a. Test Status

Before the test, temperature and humidity must meet requirements, static pressure difference, Ventilation frequency, and air flow rate must be controlled
The clean room must be disinfected before testing
Two test states: static and dynamic
Static test: clean room purification and Air conditioning system in normal operation
Dynamic test: clean room in normal production

b. Testers

Testers must wear work clothes that meet the environmental cleanliness level
Static test: all equipment installed but not running, max 2 testers
Test time for unidirectional flow (e.g., Class 100): at least 10 minutes after system operation
Test time for non-unidirectional flow (e.g., class 10000/100000): at least 30 minutes after system operation
Dynamic testing: equipment operates as planned with specified operators

c. Test Steps

Sampling: Place culture dish according to sampling point layout, open cover for 0.5 hours, then cover and turn upside down
Culture: Place upside down in incubator at 30~35℃ for at least 48 hours
Colony counting: Count with naked eye, mark on colony counter, verify with magnifying glass