Hi Joan

When moving materials from a lower classification to a higher classification transfer disinfection will be done with a sporicide followed by a suitable alcohol based sanitizer (i.e. 70% IPA or 70% Ethanol) to remove the residue.

After completion of the laboratory disinfectant efficacy study you should demonstrate the disinfectants used are suitable under in use conditions in the manufacturing environment.  Conditions such as temperature, air changes, and technique of application may have an impact on the effectiveness of the disinfectant.

The approach we are taking is that only materials and equipment that have been included on an approved list, developed during validation of the transfer disinfection process, will be allowed to be transferred into the Grade A or Grade B area via an airlock or pass-through hatch.  Equipment and materials (intended for use in the Grade A zone) will be protected when transiting through the Grade B cleanroom.  Any unapproved items that require transfer will be pre-approved by QA as an exception. Appropriate risk assessment and mitigation measures will be applied and a specific disinfection and monitoring program approved by QA.

Scott


-----Original Message-----
From: Joan <[log in to unmask]> 
Sent: Thursday, April 30, 2020 11:41 AM
To: [log in to unmask]
Subject: [PMFLIST] material transfer process

NOTICE: This message originates from an external source.
________________________________

Dear Forum,

How are you handling the material transfer process of items from unclassified area to classified area, as well as from class C or B to a grade A laminar airflow cabinets (sterile production). What disinfectant and method do you use at each step, and do you use a sporicide and/or IPA/ethanol to disinfect the items? How do you handle possible disinfectant residues? What about items, like single use sterile materials, that are packed in paper and cannot be disinfected multiple times?

How are you planning to approach the upcoming changes in new GMP Annex 1 that introduces the need to have a validated list of items transferred in with the process and chemistry used to disinfect the items?

Best regards,

Joan

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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.