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

USP 797 INDEX

Preparations:

Are you prepared?

USP 797 Training

Solutions:

USP 797 Compliance
Solutions

On-Site USP 797
Gap Analysis Request

Opinions:

Micro-Clean's Position
on US 797

Sterile Preparations Documents:

USP 797 Pharmaceutical Compounding – Sterile Preparations

Update of USP 797 Document

JCAHO Timeline

Supplies & Equipment:

USP 797 Supplies & Equipment

USP 797 Compliance Resources

Device and HEPA Filter Certification:

• Biological Safety Cabinets, Class I, II, and III
• Laminar Flow Clean Benches
• Compounding Isolators
• ISO Class 4 through ISO Class 8 Cleanrooms

Consultant to Pharmacy Personnel on compliance with USP 797

NIOSH issues Alert!

• "Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings".

(Environmental Monitoring) Non-viable particle counting per ISO 14644-1

Calibration and sale www.hepafilters.com of particle count monitoring equipment

Purchase ISO 14644-1 www.iest.org or www.microcln.com

Purchase USP 797 www.usp.org

Enironmental Monitoring Viable sampling, surface and air on ISO Class 5-8 rooms and devices

• Development of customer viable monitoring sampling plans
• Trend analysis
• Establishing Alert and Action limits
• Calibration of viable monitoring equipment link to calibration
• Consultation and sale of viable monitoring equipment

Temperature mapping and calibration of pharmacy refrigeration equipment

Training of Pharmacy personnel on ISO 14644-1 Particle Counting and Viable Monitoring link to Environmental Monitoring

Training of Pharmacy personnel on proper aseptic gowning

Annual Practical Evaluation on proper Aseptic Gowning of Pharmacy Personnel

Annual Testing and Practical Evaluations and Materials on proper Aseptic Processing

Temperature and humidity control of Buffer area

Sale and Calibration of temperature and humidity chart recorders link to calibration and www.hepafilters.com

Facility Environmental Controls

Aid in designing new or upgrade cleanrooms and links to installers www.hepafilters.com

Facility Air Balance

Background on USP 797

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