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.

 
Phone: (302) 834-3344 or (800) 207-7647 FAX: (302) 834-5157
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