Entry & Exit procedure for manufacturing room of SVP section
Entry & Exit procedure for manufacturing room of SVP section
PURPOSE:
To lay down the written procedure for entry & exit for Clean area Manufacturing.
SCOPE :
This SOP is applicable for authorized staff & visitor’s movement in manufacturing area of SVP Section.
REFERENCE(S) & ATTACHMENTS
References
In-House
Attachments
Attachment-I: Clean Area entry & exit record
Attachment-II: Authorized Person list for manufacturing area
Attachment-III: Pictorial Diagram for entry & exit for staff & visitor
RESPONSIBILITY
Concern Department Person:
To follow this SOP for entry & exit for clean area manufacturing room.
To Maintained the record.
Production Head:
To verify that employees are trained before performing or operation any task relevant to this SOP.
Quality Assurance Persons
To verify that all the instructions are followed properly as per given SOP.
To ensure implement of the SOP.
DISTRIBUTION:
Production
Quality Assurance
DEFINITION & ABBREVIATION(S)
Clean Area :Clean area is the area in which defined environmental control of particulate & microbial contamination, constructed & used in such a way to reduce the introduction,
generation & retentions of contaminants within the area.
Abbreviations
SOP : Standard Operating Procedure
QA : Quality Assurance
SS : Stainless Steel.
IPA : Iso Propyl Alcohol
LAF : Laminar Air Flow
7.0 PROCEDURE:
Entry & gowning procedure in the clean area manufacturing Room
To entry in the clean area manufacturing room, enter in the classified production corridor with proper entry procedure as per SOP.
For the authorized staff to enter in first air lock use biometric access control system(finger detection) system & make entry in the entry/exit record for investigation Purpose.
Outside party person, visitor or untrained person shall be accompanied with authorized person for entering.
After entering in first air lock of clean area manufacturing remove the factory ware, personal ware (except under garments), factory slipper & keep in the assigned place in
SS dress cabinet with proper manner & sanitize hands with hand sanitizer & dry atmospherically.
Enter in the Personnel Air Lock-II by opening the respective door with elbow.
Open the dynamic garment cubicle, wear sterilized primary gloves & collect the sterilized Dacron gowning bag (green colour ) from the cabinet as per step IV.
Open the bag & first wear sterilized headgear, ensure that all hairs are covered.
Wear sterilized dangri tucking headgear inside neck of gown. close the zip of dangri.
Wear booties tucking lower portion of gown inside the booties. Be carefully during gowning, it should not touch on the floor. gowning to be followed as per step V.
If the gowning found torn or dirty or not fit to the body keep it in SS “ USED GARMENT BIN”.
Wear sterilize secondary gloves & sanitize hands with IPA 70% v/v solution as per step VI.
Check yourself in front of mirror for proper gowning & avoiding any expose body parts as per step VII.
Enter in air lock III by opening door as per step VIII..
Sit & swing over the cross over bench & enter in buffer zone by opening the door of same as per step IX.
Through the buffer zone enter in sterile corridor/cool zone by opening the door of same.
Enter in the manufacturing room for further processing.
Exit & degowning Procedure from the manufacturing Room
To exit from the manufacturing room, open the door in return way, enter in buffer zone.
Enter in personnel air lock-IV by opening respective door in return way & remove clean area shoes & keep inside cross bench as per step X.
Remove primary & secondary gloves & keep in SS waste bin.
Remove clean area booties, dangri, hood & keep the gowning in used dress bin subjected for washing as per step XI.
Enter in first air lock by crossing C.O.B & collect personal ware, factory ware & factory shoes from SS cabinet & wear the same as per step XII.
Exit from first air lock to main corridor by opening respective door as per step XIII.
Mention the exit time in the entry/exit record.