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Facility & Process Validation

Facility & Process Validation

According to the Quality System Regulation Definitions 21 CFR 820.3(z)(1), the process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Manufacturing facilities and processes can be a primary source of product contamination. Facility and Process Validation is a process used to evaluate the manufacturing environmental conditions, as well as water system validations, raw material screening, and residual manufacturing material tests under specification guided by EP, USP, or ISO. This test is applied to monitor and eliminate the source of product contamination.

"Process Validation: General Principles and Practices", the FDA guidance document for industry, gives out the general considerations that FDA considers should be taken into account when evaluating the process validation of a medical device. It outlines the principles and approaches that appropriate elements of process validation for the manufacture of human and animal drug and biological products.

STEMart offers comprehensive facility and process validation for your medical devices. With extensive expertise in Microbiology & Sterility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.

Our Facility & Process Validation services

Disinfection Efficacy Studies

We offer disinfection efficacy studies to validate sanitizing agents for effectiveness against organisms.

Filter Testing

We offer filter testing to evaluate a filter’s ability to filter out microbial organisms of various sizes. This test allows manufacturers to determine membrane pore sizes.

Forced Degradation

We offer force degradation studies to identify reactions which may occur to degrade a processed product.

Material Characterization Screens of Raw Materials

We offer raw materials screening service as a part of incoming supply quality controls to help manufacturing production and process controls.

Residual Manufacturing Materials

We offer residual manufacturing materials service to evaluate the overall surface cleanliness of newly manufactured medical devices and targeting contaminants form the manufacturing and cleaning processes.

Water System Validations & Monitoring

We offer water system validations and monitoring service to help manufacturers assess water system microbial and chemical content.

Environmental Monitoring

Our environmental monitoring demonstrates the control of viable (living microorganisms) and non-viable particles in critical areas.

STEMart performs cost-effectiveness full services that deliver reliable results for your medical devices. Our experts can evaluate the medical device to propose an appropriate plan for testing to ensure your medical device meets the required regulatory compliance. If you have any additional questions about Facility & Process Validation or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

  • FDA Guidance for Industry: "Process Validation: General Principles and Practices".

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