Transfer of Material/Equipment in Aseptic area
This article describes about what must be done when Transfer of Material/Equipment in Aseptic area.
Transfer of Material/Equipment in Aseptic area
What can be done when materials and/or equipment are being transferred into a Grade A and Grade B aseptic processing area?
Guidance :
Sterilized materials and equipment should be transferred into the Grade A and Grade B aseptic processing area using the following methods and taking these precautions:
• The preferred method for transferring sterilized materials and/or equipment into an aseptic processing area is by using a unidirectional sterilization process (e.g., through an attached double door autoclave or a depyrogenation tunnel) where materials or equipment cannot be sterilized directly into Grade A, they must be transferred into and through the Grade B area while being protected from particulate and microbiological contamination e.g., multiple wrapping.
• Pre-sterilized items that are transferred into the Grade A and Grade B area should be contained in sealed packaging and disinfected prior to transfer into the Grade B area and subsequent transfer into the Grade A area. The integrity of the packaging should be qualified and visually verified prior to use. The packaging material should be compatible with the disinfecting method and agent. Multiple layers of protective wrapping material should be sequentially removed as the items are transferred from areas of lesser to greater control (e.g., Grade C to Grade B, Grade B to Grade A). Where possible, the use of rapid transfer port technology should also be considered.
• Items that have been packaged with multiple sterile packaging layers need not be stored in a cleanroom if the integrity and configuration of the packaging allows the items to be disinfected during transfer into grade A (e.g., by use of multiple layers that can be removed at each transfer from areas of lesser to greater control).
• Where materials and/or equipment are sterilized in sealed packaging and then transferred into the area, this must be done, for example, via airlocks or pass-through hatches with accompanying disinfection of the exterior of the transfer packaging.
• For materials and/or equipment that are necessary for aseptic processing but are not amenable to sterilization (e.g., lubricant containers or electronic instruments), an effective and validated disinfection process must be in place. If possible, equipment should remain in the aseptic processing area to minimize the risk of repeated transfers.
• Only items that are on an approved list should be allowed to be transferred into the Grade A and Grade B area via the air lock. Any unapproved items that require transfer should be covered by a deviation that includes a specific sanitization and monitoring regime derived by consultation with quality assurance and microbiology personnel.
Above Methodology can be used to Transfer of Material/Equipment in Aseptic area.
