Cleanroom & Facilities Monitoring

Laboratory
Cleanroom & Facilities Monitoring

Facilities might be a source for production contamination. Therefore, periodically monitoring is needed to ensure the environment in a good condition. Below is a flowchart for monitoring processes.

01

Review manufacturing procedures

a. Movements of materials

b. Personnel practices

c. Cleaning and disinfection procedures

02

Visit production and packaging areas. Observe manufacturing process

03

Evaluate possible sources of microorganisms and potential to impact product bioburden.

04

Formulate sampling plan

a. Prepare production area schematic.

b. Identify sites for air sampling and surface sampling.

05

Collect environmental samples

06

Incubates samples at temperatures appropriate for the various environmental samples

07

Following incubation, bacteria and mold colonies are enumerated

08

Results are reported to client.

At SaniChem, we offered a wide range of testing to access the environmental conditions:


1. Sponge Swab- Surface
2. Contact plate- Surface
3. Hand Swab- Personnel
4. Passive Air Sampling- Air
5. Active Air Sampling- Air
6. Technician & Onsite Sampling
Reference Standards:
1.    ISO 14644
2.    ISO 18593
3.    USP <1116>

Test Code
Test Method
MB106a
Active sampling for total plate count
MB106b
Active sampling Test for aerobic bacteria
MB106c
Active sampling Test for Yeast and Mold
MB106d
Open Plate exposure for total plate count
MB106e
Open Plate exposure for aerobic bacteria
MB106f
Open Plate exposure for Yeast and Mold
MB106g
Hand swab test for total plate count
MB106h
Hand swab Test for aerobic bacteria
MB106i
Hand swab Test for Yeast and Mold
MB106j
Sponge-Swab Test for total plate count
MB106k
Sponge-Swab Test for aerobic bacteria
MB106L
Sponge-Swab Test for Yeast and Mold
MB106m
Surface contact plate analysis for total plate count
MB106n
Surface contact plate analysis for aerobic bacteria
MB106o
Surface contact plate analysis for Yeast and Mold

Please call for on-site sampling services.

 

Exposed plates may be incubated by SCR

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