Cleanroom & Facilities Monitoring
Medical Device Testing Training Program
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 offer a wide range of testing to assess 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
