Validation

Reduce Costs Smartly

Pressured to reduce costs, medical device manufacturers should fully understand ISO 11607 requirements and move forward with an educated approach to cost cutting.

Medical device manufacturers are often pressed to take costs out of a product over its lifetime, but they cannot risk any threats to quality.

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Finding the Right Validation Package

Enlist your equipment provider to help you ensure quality and repeatability from your packaging process.

By Wil Caraballo, Technical Manager
Multivac Inc. (Kansas City, MO)

For pharmaceutical and medical device manufacturers, process validation is required under the Good Manufacturing Practices (GMP) regulations 21 CFR Parts 210 and 211 and 21 CFR Part 820, respectively. Within the regulations, there are several areas of manufacturing that process engineers must address to comply with these standards. Validating packaging machinery processes is crucial for compliance.

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Finding the Right Validation Package

Enlist your equipment provider to help you ensure quality and repeatability from your packaging process.

No votes yet
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