Validation Services

Validation Services

Process Validation Services

Perhaps you’ve purchased a new TFFS line that requires full validation or moved an existing line to a new location. Whatever the scenario, if your engineering staff is stretched too thin to meet your deadlines, Oliver™ OnSite process validation services can help. Count on us to expedite protocol and report development, supervise OQ/PQ runs, analyze data, or help in any way you need us.

In the end, OnSite helps you meet deadlines and leaves you confident that your robust process validation meets established regulatory requirements.

Deliverables

Phase 1: OQ/PQ protocol authored

  • ISO 11607 compliance
  • Process limits challenged (temperature, pressure, dwell)
  • Process variation evaluated (run to run)
  • Acceptance criteria defined

Phase 2: Execution of OQ/PQ protocol at customer site OnSite engineer present for technical support

Phase 3: OQ/PQ testing

  • Seal strength
  • Burst
  • Integrity

Phase 4: OQ/PQ data analysis

Phase 5: OQ/PQ report authored

Package system validation services

You’re getting ready to launch a new product, and time is of the essence. But the package engineer who conducted the last packaging system validation is no longer with the company. Where can you find the protocol and report development, ISO 11607, transportation testing, and stability study expertise you need right now? Look no further than our OnSite package system validation services.

Our OnSite team has experience with ASTM D4169 and ISTA simulated distribution methodologies. We can analyze your current distribution network and help you set up a realistic transportation test. We can walk you through the steps needed to establish a valid stability study, one that demonstrates that expiration date claims are appropriate. Finally, OnSite can assist you by demonstrating biocompatibility via cytotoxicity testing to ensure no adverse impact to the patient. Let OnSite team members help you get that new product to sterilization standards.

Deliverables

Phase 1: Transportation test

  • Protocol authored
    • ISTA, ASTM D4169
    • Shock, vibration, environmental conditioning, compression
  • Integrity testing
  • Report authored

Phase 2: Stability test

  • Protocol authored
    • Accelerated aging
    • Real-time aging
  • Seal strength testing
  • Integrity testing
  • Report authored

Phase 3: Biocompatibility/Cytotoxicity (ISO 10993)