| |
|
| |
|
| |
FDA
and European regulated facilities constantly battle a bio-burden war within
the cleanroom envelope. Aggressive cleaning procedures, rotating disinfectant
solutions and Space/Equipment Decontamination
processes are employed to keep microbial counts under control. Code of Federal
Regulations 21 Parts 210, 211, 600 and 820 address facility design, cleaning,
inspection and licensing. Alpha Engineering, Inc. and its division,
Alpha Pharm Tech, have Engineers and Cleanroom Technicians who are
very familiar with these regulations as well as current Good Manufacturing
Practice (cGMP). |
| |
AEI personnel will develop qualification test procedures for your
cleanroom and all critical utilities such as Water For Injection, Clean
Steam, Compressed Gases, etc., collect all samples and provide laboratory
results from our affiliate. All procedures and results are properly documented
to meet cGMP requirements.
|
| |
AEI and Alpha Pharm
Tech division provides this service for initial qualifications on new
or retrofit facilities. On-going cleanroom monitoring and routine qualifications
are provided under contractual arrangements to maintain Cleanroom Quality
Standards. |
| |
Alpha
Pharm Tech also provides Space/Equipment
Decontamination services using modern techniques and materials superior
to old fashion, unreliable and unsafe methods such as paraformaldehyde
gassing and chlorine bombs. Click on the link to learn more.
|
| |
|
