Sterility Validation and OEL testing

  1. OEL testing
  2. Isolator Gas cycle development
  3. Validation of isolators


OEL testing

As market leaders in the containment industry, Automed along with its partners, offer OEL testing for all our supplied equipment and to existing facilities and equipment at clients plants.

High Potent Active Pharmaceutical Ingredients (HPAPI) have started becoming more and more important in the drug development sectors and therapeutics. Especially in the Oncology, Harmone and Direct drug delivery systems. HPAPI provide a wide range of challenges in containment requirements both for operators and for manufacturing facilities. These can be designed and Validated only by a Validated OEL Test.

The main purpose of OEL test is to demonstrate that installed equipment delivers on the stated OEL protection its designed & claimed for. The test is performed in accordance with the recommendations, the guidelines from association ISPE.

OEL Validation is one of the many tests performed for ensuring isolator & valves performance. Other tests include filter integrity test, chamber leak test, air flow pattern test, light intensity test and recovery test.

Under our OEL Testing service, our trained Engineers determine the equipment’s occupational exposure limit. This is done for identifying the amount of drug substance coming out of the equipment and gets exposed to the environment during the compounding process. This measurement is especially critical at the inhaling level of Operators.

Contact our engineers for assessing your operators exposure levels testing needs.


VHP cycle development for isolators and valves

Integrated VPHP systems are commonly used across industry for clear aseptic environment.

To meet regulatory requirements, the Dehumidification, Conditioning, VHP generation & Injection, distribution, dwell and aeration needs to be precisely controlled and validated to achieve necessary sterile environment.

Implementation involves cross-functional teams with a thorough knowledge of production processes. The study and development will involve a detailed Risk analysis, Load assessment, Chemical and Biological Indicator evaluation and a complete validated approach towards setting the Cycles.

Over the years Automed team has developed expertise in optimising VHP cycle times for isolators and valves and offers it as an added service for our customers.

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Validation of Isolators

With over twos decade of experience in Containment and aseptic processes Automed has extensive knowledge on installation, commissioning and validation of isolators. Be it negative pressure Containment Isolators or Positive pressured Aseptic Isolators, the challenges of Validation remain the same.

We have perfected the full spectrum of Tests and Documentation required which will ensure complete acceptance of the process.

The process will include HEPA Filter Integrity Test, Air Flow Visualisation Tests, Particle Count Test, Air Velocity Measurement, Light Intensity Tests and Sond Level Tests.

Validation process will cover the entire gamut of evaluation and documentation

  • Validation Master Plan
  • User Requirement Specification.
  • Functional Requirement Specification
  • Design Qualification
  • Risks Assessment
  • Installation Qualification
  • Operation Qualification
  • Performance Qualification

Process Instrument Calibration also plays an important role in the validation process. Gauges, pressure sensors, temperature sensors and other measuring systems will need to validated and calibrated.

An additional service and evaluation that can be offered is the 21 CFR Part 11 compliance tests and validation. These will include evaluating existing software for compliance and advise correction methodologies.

A Compliant Installation will save a thousand heartaches. Contact us for the solution.