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Facility & Process Validation


Applicable Standards

  • EP
  • USP
  • ISO
  • AAMI
  • ASTM

Services Summary

Manufacturing facilities and processes can be a primary source of product contamination. Nelson Labs offers a range of services to assess these manufacturing environmental conditions, in addition to water system validations, raw material screening and residual manufacturing material tests.

Environmental Monitoring for Facilities

Environmental monitoring includes auditing the key components of a controlled environment including water, air, surfaces, equipment and personnel. Nelson Labs offers environmental monitoring supplies (surface, air plates) as well as water monitoring supplies (bottles with and without thiosulfate) to assess microbial controls in manufacturing facilities. Test services for plates and water samples may be submitted to the lab for analysis.

Filter Sterilization Validations

For pharmaceutical and liquid products that require sterile processing, Nelson Labs offers filter validation services to evaluate a filter’s ability to remove chemicals or microbial organisms of various sizes. This test allows manufacturers to determine membrane pore sizes and is an excellent lot release test in compliance with both the ASTM F838-05 and HIMA guidance documents.

Raw Materials Screening

Screening raw materials as part of incoming supply quality controls is an essential part of manufacturing production and process controls. Depending on the type of material or supply, the manufacturer may be interested in microbial content (sterile and nonsterile), material composition and qualitative assessment of parts to assess changes in materials. Nelson Labs offers both analytical and microbiological tests to make these assessments. In addition, relatively inexpensive qualitative tests may be performed to ensure raw material biocompatibility such as a cytotoxicity MEM elution assay.

Residual Manufacturing Materials

Cleaning validations examine the overall surface cleanliness of newly manufactured medical devices and single-use implants, targeting contaminants remaining from the manufacturing and cleaning processes. It’s important to keep in mind that just because a device is sterile, it doesn’t mean that it is necessarily clean.

Test methods are available to quantify the amount of residuals (i.e., oils, lubricants, polishing compounds, detergents and passivation residuals) on the device or implant. To give a comprehensive view of cleanliness, you can also include a cytotoxicity assessment and tests to examine the microbiological contamination.

Water System Validations

Water is one of the most common sources of product contamination and any product manufacturing process that utilizes water in the final product, as part of cleaning or processing, should be evaluated, controlled and monitored. Establishing frequency of water changes to passivation processes is also critical to minimizing microbial contaminants and bacterial endotoxin levels on finished medical products. Nelson Labs provides consulting services for installation of new water systems, validation test plans and test services to assess water system microbial and chemical content.

If you have additional questions about Facility & Process Validation testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.