Is swab test of gown required for operater after performing assembly of sterile filling machine?
Swab test of complete gown is not required. However swab of only handgloves is current practice. After assembling sterile parts swabs are taken. Then operator should change handgloves and he can continue.
Why we should not take swab of garment? Garment is not source of contamination?
As an additional assurance the swab of complete gown can be taken. But the swab of handgloves is critical.
But again the question may come that in case of any manual intervention occurs during machine operation then also swab of complete gown should be done or not…At that time also the gown can be source of contamination.
The person is handling sterile product in Grade A. However his gloves will be a more threat to product than his complete gown. Hence swab of gloves is preferred.
To assure that his gown is not shedding microorganisms (upto a certain level) and he is not contaminating the area the complete swab can be taken when he is leaving the area.
Sorry for delayed reply.
In sterile environment, after machine set up operator should do finger dabs on TSA plates and contact plates should be performed between gloves and gown( on wrist area). I have never heard of swabs test on operator’s gown. Probably, different technique!
In order to monitor the personal hygiene by contact plate/swab method.
Suit, hood, Cuff, Seat, jipper, feet, knees, both gloves.
Not a different technique…Swab test means if contact plates are not implemented then in that case swabs shall be used.
Nowadays use of contact plates is common and easy to use.
Contact plates/Rodac plates are ready made or can be prepared inhouse also.