Alpha Pharm Tech's unique qualifications provide unparalleled capabilities to perform facility evaluations. Our inspections of critical and non-critical utilities systems, cleanroom controls, people flow, product flow, waste decontamination, etc. will pre-empt the Food and Drug Administration, European Commission and other regulatory agency citations. APT engineers and technicians are thoroughly familiar with all current Good Manufacturing Practice (cGMP) and regulatory requirements for facility, equipment and product. Our experience excels in all aspects of pharmaceutical and biological production facilities as well as food, cosmetics and medical devices. Whether Class 100,000 controlled environments for topical formulation or Class 100 aseptic-fill areas, Alpha Pharm Tech personnel will evaluate your facility for sterility assurance and compliance.
 
Keep APT in mind when evaluating new or renovation facility designs as well as applying for your "Establishment License Agreement". As team members who subscribe to Team Alpha Philosophy we assist in application document production and assembly in a way that regulatory agencies prefer to see, making the application review go smoothly.
APT also provides large volume decontamination services using preferred gassing methods far superior to paraformaldehyde and other conventional methods currently used.
Click on Space/Equipment Decontamination to learn more.

Click on Cleanroom Qualification to learn more about our room and utilities qualification services for both new facilities and on-going monitoring.
   


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