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Particle Measuring Systems
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Application Note

Effective Risk Assessment in Pharmaceutical

Steps to Ensuring a Successful Audit

Risk Assessment in Pharmaceutical for aseptic manufacturingA risk assessment for pharmaceuticals is the first critical step when designing a contamination control for aseptic manufacturing. Product quality is the critical measure of success.

To ensure product quality, it is imperative that effective particle counting and microbial monitoring is set up for contamination control. The best way to locate sources of viable non viable contamination in your aseptic manufacturing is via a risk assessment, best performed before a process has been implemented.

There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.

COMPLETE THE FORM TO GET THE FULL DOCUMENT

Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
  • PMS Cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial Monitors including portable/mobile, fixed/remote, and single use.
  • Data management software from Particle Measuring Systems

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.

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Particle Measuring Systems- USA

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5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

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