Annivi R.

Dura Southwestern University - PHINMA

1. Toyoma labeled the contamination level by A,B, and C. Level A is the area
where the beta-lactams were handled. In level B, there was no handling of
beta-lactams but had material/people/product movement. Lastly the level C
is where there is no handling and no movement of beta-lactam. Their first
step was to complete risk assessment more than ^M’s, planned a
comprehensive decontamination protocol and contacted FDA for acceptance
criteria.

2. The floors,walls, ceiling and exteriors were decontaminated with a use of

reagent solution. Gypsum walls were replaced and other walls were finished
with epoxy. The concrete floors were also coated with epoxy paint. The
epoxy helps in preventing the breeding. The instruments were dismantled
and decontaminated. Utilities were decontaminated, gaskets/seals/ HVAC
were replaced. The insulation was also removed, decontaminated and
replaced. In electrecials, they were removed, decontaminated and replaced.
Except the non-explosion lighting and outlets were removed. Documents
were decontaminated as applicable and then moved to a different site.

3. Beta-Lactam bleed study, residue sampling and analytical procedures were

done to ensure complete decontamination of the areas.

4. The dismantling of the instruments was not okay because it cannot be

thoroughly cleaned. The instruments should have been disassembled.
Commitment not to use the equipment again for Non-Beta Lactums
Same employee code for 2 persons. In this case they should provide
individual employee codes for their workers. This is a problem if there will
be mistakes done in the future and they can not determine who is the one
responsible for it.
Simultaneous entry of 2 persons with 1 access card. There should be a sensor
in the point of entry to determine that a single person entered the
premises/area. Attachment of surveillance camera near the door will also
help in case this is not implemented. The problem with multiple entries is
there is no record of who was in the area. If there will be errors in the
production, a record of the people entering and exiting the area will help in
thorough investigation.