Changing Room: Estoque, Carmela Kate Q. Baria, Jemmalyn R January 21, 2017 January 21, 2017

CONFIDENTIAL and PROPRIETARY
SYNERGIA PHARMACEUTICALS
QUALITY CONTROL DEPARTMENT
STANDARD OPERATING PROCEDURE
Procedure No. QC 001.0 Page No. 1 of 3 Date Prepared January 21, 2017
Revision No. 1 Supersedes N/A Date Effective
Circulated To: QC Department (Microbiology)

.
For :
Discussion at : _________________________
(Venue/Date of Meeting)
Comments : _________________________
(Date)
Issued To:
Section : General Operating Procedures

Subject : Entry and Exit Procedure for Personnel and Visitors in Microbiology Laboratory
1. Purpose : To specify procedures for entry and exit of visitors and working personnel in the
Microbiology Laboratory
2. Scope : The specified procedures in entering and exiting the Microbiology laboratory are
applicable to all visitors and working personnel
3. Abbreviations : IPA - Isopropyl Alcohol
Nb. - Note well
QC - Quality Control
SOP - Standard Operating Procedure
VEF MB - Visitor Entry Form - Microbiology
v/v - Volume per volume
4. Definitions :
4.1 Antiseptic - something that discourages the growth microorganisms
4.2 Crossover Bench - it demarcates the line between the slightly soiled changing-zone on
entry side of the changing room and the cleaner area in front of the
entry to the clean room. It is crossed when cleanroom footwear is put
on
5. Responsibility : QC, QA, MICROBIOLOGIST

6. Procedure Description :
6.1 Entry Procedure for Working Personnel in the Microbiology Laboratory
6.1.1 Personnel shall enter the primary change room
6.1.2 Sitting on the crossover bench, remove outdoor footwear and store it in the box at the
uncontrolled area.
6.1.3 The personnel shall get a pre sterilized foot cover from the cabinet and wear it before stepping
over the controlled area
Prepared by: Estoque, Carmela Kate Q. Checked by: Baria, Jemmalyn R. Authorized by:
Date: January 21, 2017 Date: January 21, 2017 Date:
Review or update on _______________
Procedure No. QC 001.0 Page No. 2 of 3 Date Effective
6.1.4 Personnel shall enter the controlled area of the primary change room by stepping on the other
side of the crossover bench
6.1.5 Take off all outdoor clothes, accessories and personal belongings and placed all in the personal
locker
6.1.6 Get a companys uniform from the locker located beside the personal lockers and wear it in the
designated changing area
6.1.7 Wear in an appropriate order, the pre-sterilized gown, head cap, nose mask and hand gloves.
6.1.8 Check and see self in the mirror to make sure that gowning is properly done. If gowning is
inappropriate, check sample picture for appropriate gowning before proceeding to the next step
6.1.9 Personnel shall enter the secondary change room
6.1.10Disinfect hands with 70% v/v IPA or Antiseptic soap and rub hands for drying
6.1.11Wear sterilized gown, nose mask, head cap, foot cover and hand gloves overlapping the pre
sterilized protective equipment
6.1.12Check and see self in the mirror to make sure that gowning is properly done before entering the
Microbiology Laboratory. If gowning is inappropriate, check sample picture for appropriate
gowning before proceeding to the next step
6.1.13 Disinfect hands again with 70% v/v IPA or Antiseptic soap and rub hands for drying
6.1.14 Open the door and enter the Microbiology Laboratory
6.2 Exit Procedure for Working Personnel in the Microbiology Laboratory
Nb. Opposite of Entry Procedure for Working Personnel in Microbiology Laboratory
6.2.1Personnel shall exit from the Microbiology Laboratory by entering the secondary change room
6.2.2Personnel shall remove his/her sterilized hand gloves, foot cover, head cap, nose mask and gown
6.2.3Personnel shall proceed to the controlled area of the primary change room and remove his/her
pre sterilized hand gloves, head cap and gown.
6.2.4Personnel shall place the companys uniform in a laundry basket located near the door and
change into his/her outdoor clothes
6.2.5Using the crossover bench, personnel shall remove his/her pre sterilized foot cover and cross to
the uncontrolled area of the primary change room.
Procedure No. QC 001.0 Page No. 2 of 3 Date Effective
6.2.6Sitting on the crossover bench, personnel shall wear his/her outdoor footwear.
6.2.7Personnel shall exit from the uncontrolled area of the primary change room after completion of
wearing his/her personal belongings.
6.3 Entry Procedure for Visitor in the Microbiology Laboratory
6.3.1 Log in the VEF MB located outside of the primary change room. Fill in the following
information: Name, Purpose, Time in
6.3.2 After filling the necessary information, sign the form
6.3.3 Perform Procedure 6.1.1 to 6.1.14
6.4 Exit Procedure for Visitor in the Microbiology Laboratory
6.4.1 Perform Procedure 6.2.1 to 6.2.7

6.4.2 Log in the VEF MB located outside of the primary change room. Fill the time out and sign
the form
7. List of Attachments :
7.1 Attachment # 1 Visitor Entry Form Microbiology 1 page
7.2 Attachment # 2 Sample Picture of Appropriate Pre sterilized and Sterilized Gowning 1 page
8. Revision History :
8.1 Revision No.1 - Added Nb. To Abbreviations

- Specific working personnel and visitors are indicated in responsibility
- Changed gray side to uncontrolled area
- Added procedure on entry procedure for working personnel in the microbiology
laboratory under procedure 6.1
- Added procedure on exit procedure for working personnel in the microbiology
laboratory under procedure 6.2
- Noted that exit procedure for working personnel is the opposite of the entry
procedure for working personnel
- Editorial changes
9. End of Document

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CONFIDENTIAL and PROPRIETARY

STANDARD OPERATING PROCEDURE

Circulated To: QC Department (Microbiology)

Section : General Operating Procedures

5. Responsibility : QC, QA, MICROBIOLOGIST

STANDARD OPERATING PROCEDURE

Procedure No. QC 001.0 Page No. 2 of 3 Date Effective

6.1.9 Personnel shall enter the secondary change room

6.1.14 Open the door and enter the Microbiology Laboratory

6.2 Exit Procedure for Working Personnel in the Microbiology Laboratory

Nb. Opposite of Entry Procedure for Working Personnel in Microbiology Laboratory

STANDARD OPERATING PROCEDURE

Procedure No. QC 001.0 Page No. 2 of 3 Date Effective

6.3 Entry Procedure for Visitor in the Microbiology Laboratory

6.4 Exit Procedure for Visitor in the Microbiology Laboratory

6.4.1 Perform Procedure 6.2.1 to 6.2.7

7.1 Attachment # 1 Visitor Entry Form Microbiology 1 page

8.1 Revision No.1 - Added Nb. To Abbreviations

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