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Validation

LyoWorks offers validation services for your lyophilizer. 

Installation & Operational
Qualification

LyoWorks offers IQ/OQ validation services for your lyophilizer.  IQ is the initial step in the validation process and focuses on verifying that the equipment or system has been installed correctly and meets all the required specifications.  OQ is the subsequent step in the validation process, following IQ. OQ aims to demonstrate that the equipment or system operates as intended within its specified operational parameters.

Performance
Qualification

LyoWorks can perform PQ on your lyophilizer.  Conducted after IQ/OQ, Performance Qualification is a phase of the validation process that is conducted to ensure that a system, equipment, or process consistently performs as intended within its specified operational parameters.  Performance Qualification often involves running test scenarios, simulating various operating conditions, and collecting data to evaluate the system's performance. It may include activities such as stress testing, endurance testing, stability testing, and measurement of key performance indicators.

Save time getting into production by having LyoWorks come in to perform the validation for you.

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