Sterilization Validation and Product Validation

Validation of sterilization and control of microbiological contamination is of paramount importance to ensuring the safety of medical devices and preventing infection in hospitals.

Bhargava Consulting Group has vast experience in validation and testing at your disposal to help define the most efficient path forward for this critical processing step.

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Bhargava Consulting Group has the expertise to perform sterilization validation studies using Ethylene Oxide, Gamma, or Steam as appropriate to support ANSI, AAMI, and ISO 11135, 11137, and 17665 standards. In addition, we can review your microbiology processes to ensure regulatory compliance, including environmental monitoring and clean room evaluations, bioburden monitoring and trending programs, package shelf life evaluations; and on-site steam sterilizer validations.

Sterilization Validation

Bhargava Consulting Group has the expertise to design regulatory accepted sterilization validation studies using ethylene oxide, gamma, or steam (moist heat) as appropriate to support ANSI, AAMI, and ISO 11135, 11137, and 17665 standards. We design and coordinate the execution of studies for the validation of sterilization processes at your site (field validations) or at a contract sterilization facility.

Small Batch Sterilization

Bhargava Consulting Group can guide you through the sterilization process for the release of products from a single batch during research and development or for clinical trial products or using the batch release approach as part of a full validation study.

Assessment of Product Changes

The knowledgeable, experienced staff at Bhargava Consulting Group are able to evaluate the impact of changes to manufacturing operations, product or packaging configurations, or sterilization processes on your validated processes. We can also guide you through required documentation including creating a sound rationale or the design of cycles and testing needed to support the change.

Microbiology Process Evaluation

Environmental control is a requirement of all Good Manufacturing Practices and monitoring, trending, and ongoing evaluations are key to maintaining control in your manufacturing operation or your microbiological laboratory.

Bhargava Consulting Group can help meet the requirements of the quality system regulation of your operation or laboratory by helping you design and optimize your monitoring programs, and through clean room evaluations and sterilizer validations. We can assist you with the setting of action and alert limits for your product and area monitoring.

Bhargava Consulting Group's expertise includes:

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1. Environmental monitoring

2. Bioburden monitoring

3. Trending programs

4. Clean room evaluations

5. On-site ethylene oxide and steam sterilizer validation