Providing Cleanroom Certification, ASHRAE 110 Testing, Calibration, Decontamination, USP 797 Solutions, Compressed Air Line Testing, Environmental Monitoring and Qualification Services

USP 797 INDEX

Preparations:

USP 797 Training

Solutions:

USP 797 Compliance
Solutions

On-Site USP 797
Gap Analysis Request

Sterile Preparations Documents:

USP 797 Pharmaceutical Compounding – Sterile Preparations

USP 797 Compliance
Resources

Supplies & Equipment:

USP 797 Supplies & Equipment

WHAT EXACTLY WILL I NEED TO CHANGE TO BE USP797 COMPLIANT?

• COMPOUNDED STERILE PREPARATIONS
  (CSPs) must be manipulated inside ISO
  Class 5 (Class 100) Laminar Airflow
  Workbenches (LAFW) OR Compounding Isolators
• Rooms with LAFWs must meet USP797
  ISO Classification for Cleanliness
• Cleanroom should be constructed to promote
  CLEANING & SANITIZATION and to
  prevent contamination buildup
• Materials compatible with Cleanroom Construction
• Aseptic Gowning for Personnel
• Temperature and Humidity Control
• Airborne Viable Monitoring Schedule &
  Evaluation

MICRO-CLEAN CAN HELP!

How Micro-Clean can help you:

• We have solutions to all your environmental control and testing needs.
• You will be protecting your patients and your business.

  Component Systems starting at $5,000
  Certified, COMPLETE
  SYSTEMS starting at $18,000.
  
  
  Phone
  (800) 523-9852
  (610) 867-5302
  Fax
  (610) 954-7803

• E-Mail address USP797@microcln.com

• Web Address http://www.microcln.com

  
  Micro-Clean, Inc.
  P.O. Box 21806
  Lehigh Valley, PA
  18002-1806
  
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Pharmacy
Cleanroom
per ISO 14644-1 Standards
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