Lyophilizer, qualification

Lyophilizer Qualification Some Practical Advice Thorsten Fischer... 

The lyophilizers are cleaned using a validated clean-in-place (CIP) cycle using hot WFI. After the cleaning process, a validated sterilization cycle is mn. The qualification of the steam sterilization cycle was performed during the operation qualification (OQ) of the lyophilizer. 

SUBJECT Lyophilizer Performance Qualification Summary Report... 

Equipment Qualification (EQ) is a useful endeavor when the lyophilizer is a complex and sophisticated system. Large-scale manufacturing units commonly include multiple automated support operations. These may include steam-in-... 

The Installation Qualification consists of a description of the lyophilization equipment, a system hardware and component list, the documentation of the installation procedures, and the equipment start-up and operator training. The IQ also includes references to the purchase specifications, engineering review, and SOPs. The objectives are to assure that the equipment design and construction are appropriate for the intended use, it is installed properly, the utilities are suitable and adequate, and that procedures are in place for proper maintenance and operation. 

In addition to the qualification of the lyophilization process itself, it is usual to collect liquid samples at various stages of the manufacturing. In this way, the losses in active material or its degradation can be monitored throughout the process. 

For the first round of development it is prudent to attempt to fit a product and process within an existing operational capability. The first source of information to seek is the operational qualification (OQ) data quantifying the functional capabilities and performance of the lyophilizer. Table 6 outlines a list of performance capabilities of interest that allows a sufficient assessment of equipment functions and performance. 

Process flow, variables, and responses lyophilized products Qualification of process equipment test functions and acceptance criteria... 

The documents described, namely, System Qualification Procedures (SQPs) and Standard Operating Procedure (SOP) in Figure 1 contain a generic risk assessment for determination of the validation scope and effort on the equipment lyophilizer. They were also used as a generic validation master plan for the project. Management of the project resources, costs, and deadlines was performed with a model created in a standard project planner. 

The process for equipment qualification is documented in the Aventis Behring (AB) System Qualification Procedure for lyophilizers. 

Operational equipment testing was performed for the vacuum, temperature, and ventilation system, the stoppering function, and the sterilization process. The qualification of the lyophilizer s Sterilization-in-Place (SIP) system is performed similar to an autoclave and uses biological indicators and accumulated lethality (Fq) determination (2,5). 

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