H.6 investigation summary: product complaint during manufacturing of material 221270, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record was reviewed for batch 2033845 was satisfactory and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include bioburden testing.A sample of plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.All bioburden testing performed on this batch was satisfactory per bd internal procedures.Affected product does not have any sterility claims; the product is tested for bioburden prior to release to ensure that it conforms to product specifications.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and two other complaints have been taken on batch 2033845 for contamination.No retention samples for this batch were available for investigation.Three photos were received.Photos one, two, and three show red colonies on plates with lot number 2033845 and timestamps at 0812, 0810, and 0811 respectively.No return samples were received for investigation of this complaint.This complaint can be confirmed.No complaint trends for contamination have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination.Risk management file review assessed the potential risk for the defect as severity 1, per baltrmppmselectiveaph, rev 02, id 6.13.
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