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Hardware Validation
and Maintenance Services

Regulatory Guidance
The need to qualify and validate equipment and test methods is described in various compendial and regulatory guidance documents. For example;

EU GMP directives 91/356/EEC and 91/412/EEC
"Premises and equipment intended to be used for manufacturing operations which are critical for the quality of the products shall be subjected to appropriate qualification.”

21 CFR 211.84 (d) (2). Testing and approval or rejection of components, drug product containers, and closures. “...the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.”

21 CFR part 211.194 (2) Laboratory records “...the suitability of all testing methods used shall be verified under actual conditions of use”. Proving the suitability of testing method means demonstrating and documenting that, under actual conditions of use, it provides the expected results.
Validation Support
Millipore provides validation protocols to support the timely and efficient validation of our products in your environment

Complete IQ, OQ, PQ Protocol
Your choice of comprehensive, ready-to-use installation (IQ), operational (OQ), and performance qualification (PQ) protocols are written to the same standards as the protocols used to validate pharmaceutical processes. Aimed at shortening validation times and reducing paperwork our protocols assist in providing more time for busy QA/QC departments to focus on additional projects.

Protocols contain complete descriptions of all necessary activities for both proving the suitability of the test methodology and writing SOPs. They also contain all the information and necessary result worksheets you need to support the organization, execution and recording of the validation step-by-step.

Compliance with International Compendia
All Validation Protocols comply with the United States, European, and Japanese Pharmacopeias.

Access Global Compliance Services
Methods and Applications Development
If you need to develop a microbiological test method for your new products compliant with current regulations we can offer the following support from one our Lab Service Centers:

  • Customized test protocol.
  • Definition of the required sample volume.
  • Product filterability assessment.
  • Selection of the appropriate filtration device(s).
  • Selection of the pre-wetting and rinsing fluid(s).
  • Determination of filtration and rinsing procedures.
  • Recovery evaluation on the most sensitive micro organism.
  • Checking the recovery with all other Pharmacopoeia micro organisms.
  • Complete report including detailed microbiological test method proposal
On-Site IQ/OQ Service
If you need additional support at your site location to complete validation work we are able to provide the following on-site IQ/OQ services:
  • Validation work performed by a qualified engineer.
  • Extensive training of technicians including certificate. Note: Test activities should be witnessed by at least one laboratory technician.

On-site PQ Consultancy Services
If you need additional support at your site location to complete validation work we are able to provide the following on-site PQ services:
  • On-site consulting for the implementation of microbiology Performance Qualification tests.
  • Technical training.
  • Calculation of consumables and equipment needs and test scheduling programs.
  • Data analysis support.

Rental of Calibrated Equipment
If you decide to perform the IQ/OQ on your own using a Millipore Validation Protocol we can supply calibrated equipment for rental. This equipment includes a copy of the Calibration Certificate attached to the validation report.
Equipment Maintenance
Maintenance Contracts
Once equipment has been validated, it should also be serviced regularly to ensure its performance remains compliant with the specifications, as per 21 CFR 58.63 (GLP). Millipore recommends checking and calibrating the system on a yearly basis. We currently offer a comprehensive range of maintenance services, including a service plan that includes yearly preventative maintenance, spare parts for maintenance as well as break-down repair. The Premium Service Plan also includes a certified back-up system. With our in-depth understanding of GMP/GLP procedures, we can ensure that your equipment will function properly and stay on track.

Click here to contact your local representative for more information.



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