020028.pdf, Gowning for Aseptic Filling
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STANDARD OPERATING PROCEDURE
Title: Gowning for Aseptic Filling
Effective Date: _________________
Approvals (Signature and Date):
1.
PURPOSE
1.1
2.
____________________________
QA/QC
To describe the gowning procedure for personnel entering the aseptic filling area to minimize the
potential for contamination of products.
SCOPE
2.1
This procedure pertains to the gowning performed in Room 114L prior to entering the manufacturing
aseptic filling suite to perform aseptic manufacturing and assembly in Room 114K.
2.2
This procedure does not cover gowning for bulk manufacturing. Procedures for bulk manufacturing
gowning are contained in SOP 12-0002 Clean Room Gowning.
RESPONSIBILITY
am
3.
____________________________
Technical Authority
ple
_____________________________
Responsible Department Head
4.
3.1
It is the responsibility of all personnel entering the Gowning room 114L to abide by this procedure.
3.2
It is the responsibility of all personnel to communicate to colleagues, and notify management if
necessary, of any observed deviations to this procedure.
3.3
It is the responsibility of the area supervisor to make certain that the personnel working in their area of
responsibility are trained in clean room gowning practices and to enforce its compliance.
REFERENCES AND APPLICABLE DOCUMENTS
Facility Floor Plan (Attachment A) indicating various levels of gowning.
4.2
SOP 12-0023 Use of Gowning Room 114A
4.3
SOP 12-0062 Training for Aseptic Processing
MATERIALS AND EQUIPMENT
ex
5.
4.1
(l)
5.1
Disinfecting hand soap (such as, or equivalent to Calgon-Vestal)
5.2
Cleanroom wipers (low particulating)
5.3
Sterile 70% (v/v) Isopropyl Alcohol (IPA)
5.4
Head covering (snood) and beard covering (if applicable)
5.5
Mask, sterile
5.6
Cleanroom coverall, sterile Tyvek
5.7
Hood, sterile Tyvek
5.8
Shoe covers
5.9
Sterile, non-powdered gloves or nitrile chemical resistant gloves
5.10
Sterile wrist tape
5.11
Boots, sterile Tyvek
(i)
(l)
(i)
SOP 02-0028 Rev. C
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