Entry and exit procedure; Purpose
To detail the Standard Operating Procedure for Entry and Exit in Sterility Testing Area of XX Pharmaceuticals Ltd.
Entry and exit procedure; Scope
This SOP define the Entry & Exit Procedure of personnel who will get entry & exit in sterility testing area in Microbiology Laboratory of General Building at XX Pharmaceuticals Limited.
Definitions/Abbreviations
[] Not Applicable
Responsibilities
- The roles and responsibility are as follows
- Executive/Senior Executive, Microbiology
- Follow the instructions of this procedure correctly.
Assistant Manager, Microbiology QC
- To confirm that this mentioned procedure is kept up to date.
- To confirm appropriate personnel from the section are trained on this procedure.
Head of Quality Assurance
- Take initiative approval of SOP
- To confirm the overall implementation of the SOP
Procedure
Instructions
- Only certified, trained & validated employees can enter into the sterility testing area.
- All employees are responsible to maintain their personnel hygiene & cleaning regularly.
- To follow aseptic technique during change procedure
- Always confirm sterility of the garments to be worn in the proper area.
- Always confirm that sterile garments in the Laminar Air Flow dress cabinet.
- The person infected by flue, cold, open lesions (i.e.: eczema) should not enter into sterility test area.
- Confirm that AHU[Air Handling Unit] of sterile testing area is switched on at least one hour before starting testing in that mentioned area.
Step 01: Entry into Change room- 01 (Room no: GMB012, Grade: C)
- Take away the whole garments (except undergarments), wrist watch, Jewelry, & any kind of ornaments after entering into the change room 01.
- Personal/Street shoe must be put off into shelf of the step over bench. Cross step over bench & put on dedicated shoe kept into shelf of the other site.
- Use 70% IPA from the IPA dispenser to rub Hand.
Step 02 : Entry into Change room 02 (Room Grade: C)
- Put on a pair of sterile hand gloves very carefully.
- Wear sterile primary gown having two parts (Trouser & shirts) & a hood to cover the hairs.
- Rub the hands with 70% sterile IPA.
Step 03: Entry into Change Room 03 (Room Grade: B)
- Take sterile garments from dress cabinet which was formerly kept into the dress cabinet in change room 03 of sterility testing area.
- Put on sterile dress with sterile overall, head gear, face mask, Shoes, Sterile hand gloves & safety goggles and confirm aseptic clothing. The procedure of proper clothing is described below:
Putting on Gloves
- Open the bag of sterile cleanroom latex free gloves & fold out to expose folded cuff area of the gloves.
- Put on the glove by put in the fingers into latex free glove & pulling on the folded cuff area to cover the palm, confirming that only inside of the cuff is touched.
- With gloved fingers, fold gloves over the arms, pulling them up over the wrists & forearms, confirming that gloves endure its sterility.
Putting on Hood
- Open bag having sterile hood ensuring the contents remain sterile.
- With care & only touching inside of hood, turn hood inside out & place on the head, confirming that all head is covered & no bouffant cap is unprotected.
- Clasp hood around the neck by clipping self-possessed buttons under chin.
- Being cautious not to touch outside surfaces, adjust hood to cover all of head.
Putting on Mask
[] Put on facemask & by touching as minimal area as possible tie on mask & making sure it fits comfortably.
Putting on Safety Eyewear
[] Put on sterile safety eyewear glasses remain on isolated portion of Laminar air Flow of dress cabinet.
Putting on Safety Overalls
- Open bag having sterile overall, confirming innards remain sterile. Unfold left & right sides of overall.
- Taking top folded edge of overall unfold it towards you until it is lying flat to reveal full length of zipper.
- Take hold of upper edge of each leg inaugural & gather a handful of the garment in each hand, to catch up legs of overall.
- Continue to gather garment in this way so that when overall is held up it does not touch floor.
- Lifting overall, hold in front of you & step into one leg at a time, gradually releasing gathered fabric to allow each foot to push through.
- Take care not to allow arms of overall to touch floor.
- Pull overall up to waist height, taking care not to touch outer side of the overall.
- Slip hands into sleeves, one at a time & then slip remainder of overall over shoulders.
- Check that hood skirt is completely inside collar of overall & fasten overall with the zipper.
Step 04 : Entry into Sterility testing room 04 (Room Grade: B)
- Spray gloved hands & wrists with sterile 70% IPA.
- Flashing door with help of elbow, enter into sterility test room.
Step 05: Exit from testing room
- After completion test remove used hand gloves put off into waste bin.
- Rub hands with the help of 70% Iso Propyl Alcohol
- Pull door to enter into change
- Pull door to enter into second Change room then enter into first change room.
- Take clean laboratory dress from cabinet put in the change room 01.
- Send used garments to laundry for washing.
- Enter information regarding entry exit procedures such as entry time, exit time, purpose,
- Analyst name signature in log book, Annexure-I
Download Annexure Here
Annexure I Log book of Entry and Exit Personnel of Sterility Testing Area