Washer validation

Glass vials are received from the warehouse and enter the washing area. The vials are washed in a validated vial washer, using deionized water and water for injection with sterile compressed air. The vials are depyrogenated in a validated laminar flow dry heat tunnel and unloaded into the sterile filling room under laminar flow. 

Validation/revalidation of SIP cycle freeze dryer Validation/revalidation for uniformity of heat and chilled temperature distribution in freeze dryer Qualification/requalification of vial washer (specify model) Validation of LAL test... 

The washing of components will be validated for each load configuration in the vial washer. Cycle Development Testing and Performance Qualification testing will qualify each washing process. A separate performance qualification and cycle development testing report will be written for each load configuration. The processes will be considered validated when the acceptance criteria is met for three (3) successful consecutive runs. 

It is recommended that all instalments (including microplate readers and washers) undergo validation, calibration, and routine maintenance programs established and documented to meet regulatory requirements. This eliminates instruments as a cause of poor assay performance and streamlines the assay troubleshooting process. 

Compatibility of instruments is one of the criteria to be assessed early on to assure that assays can be transferred more reliably. Incubators, plate washers, and plate readers (including analysis software) are critical in assuring comparable method performance between laboratories. Ideally, sending and receiving labs should run their methods on equivalent equipment. If not, assay conditions may have to be adapted and the assay transfer could become significantly more cumbersome, requiring additional supportive partial validation. 

Tunnels require the belt speed to be specified and coatrolled. When linked with other fixed-speed equipment such as washers and fillers, changes in tunnel belt speed often become self-evident. Temperature monitoring should reflect the coolest zone in the tunnel and include a reference sensor related to the temperature conditions recorded in the product during validation. Floating probes in the product are not usual (for reasons of practicality). 

Processing equipment such as sterilisers, component washers, filters, fillers, closure placement equipment, sealing machinery, and lyophilisers shall be qualified as part of the overall programme. Product contact surfaces shall be sterilised and process validated. 

For practical reasons, the matrix of choice for immunoassays is typically serum. The plate washers or automated systems used during sample analysis easily clog when plasma is used, which then has the potential to impact the validity of the result. Flowever, protein analytes, including cytokines that are identified as labile and prone to degradation in serum, would preferentially be collected in plasma. When collecting citrated plasma, it is wise to clearly identify the salt form of citrate (Na, K, Li) so that it is transparent what the comparable matrix should be for QC preparation. 

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