Vial/ampoule washer

Vial/Ampoule Washer Performance Qualification Protocol... 

The performance qualihcation of vial/ampoule washer is to be performed on all sizes of vials/ampoules. The tests are to be performed on X ml vial/ampoules size for pyroburden analysis on washed vials/ampoules, particulate reduction challenge test on washed vials/ampoules, and soil test to ensure vial/ampoule washer efficacy. 

This test is to assess the efficacy of the vial/ampoule washer in producing washed vials/ampoules that have low pyroburden. The X ml vials/ampoules are to be washed according to the operational parameters described for each vial/ampoule size. The results of endotoxin for each vial/ampoule size are to be entered in Table 1. 

The studies are to be performed on vial/ampoule washer using X ml vials/X ml ampoules. The vial/ampoule washer should meet the acceptance criterion for pyrogen, i.e., LT 0.25 EU/ml of rinse water in X ml vials/ampoules after washing. 

This test is to assess the efficacy of the vial/ampoule washer in reducing the particulate level in contaminated vials. Particulate matter to be determined in eight vials/ampoules, each spiked with approximately 500 particles of 40- im glass beads. A sample is to be taken from each individual needle at the end of vial/ampoule washing at set operational parameter of vial/ampoule washer and analyzed to determine the reduction in particulate level. The X ml vials/ampoules are to be washed according to the operational parameters described for each vial/ampoule size. The results are to be compared with negative and positive controls. The test results for each size of vial/ampoule are to be entered in Table 2. 

Vial/ampoule washer operational parameters for vials/ampoules... 

In the three studies performed using X ml vials/ampoules, the vial/ampoule washer should meet the acceptance criterion of NLT 90% reduction in particulate matter in each spiked vial/ampoule after the completion of washing. 

Vial/ampoule washer operational parameter for vials... 

The cleaning efficacy of vial/ampoule washer ABC was determined qualitatively by spiking ten individual vials/ampoules with 10% sodium chloride. After drying, the vials were washed at the set machine operational parameters for X ml vials/ampoules. The results were compared with negative and positive controls. The summary of test results is provided in Table 3. 

The vial/ampoule washer met the soil test acceptance criterion. All ten vials/ampoules were found negative (free from precipitates). The vial/ampoule washer was approved for X ml vial/ampoule washing. 

Study disposition the vial/ampoule washer meets the following acceptance criteria and is approved for X ml vials/ampoules ... 

Vial/Ampoule Washer Requalification Summary Report... 

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