Sop for upkeep of sterility testing area

This Document describes (Standard Operating procedure) Sop for upkeep of sterility testing area

Sop for upkeep of sterility testing area

I. Purpose & Scope:

• The purpose of this SOP is to lay down the procedure for Entry and exit procedure and upkeep of Sterility testing area.
• This Standard operating procedure shall be applicable for Entry and exit procedure, Cleaning and Environment monitoring of sterility testing area of Microbiology section

II. Responsibilities:

• All Quality control personnel’s shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

Introduction for upkeep of sterility testing area: 

• Sterility testing area is being used for analysis of sterility testing so it is important to maintain its cleanliness.
• Sterility shall be performed in LAF which is ‘Grade A’ area and adjacent area is ‘Grade B’.
• Strictly avoid entry of unauthorized persons into the testing area. Only allowed authorized persons to enter the sterility testing area. Refer Annexure III.
• Temperature and Relative humidity of the sterility testing area should be within limit.

Personnel Hygiene : 

• The personnel who are intended to go into the area were must aware of the aseptic area behaviors and their importance.
• Personnel must be shaved properly.
• Hair must be trimmed properly.
• Nails must be trimmed properly.
• No ornaments like ring/chains/watches/threads are allowed to take in to the aseptic area.
• Mobile phones are not allowed.
• Should not have cough cold, sneezing problems and other illness.
• Persons must not have any open cuts, wounds and open lesion.
• Persons must not have any skin diseases.
• Must apply disinfectant/sanitizing agent whenever he enters into the area.

Aseptic area behavior : 

• Personnel must wear the sterilized garments as per given sequence.
• Elbow length sterile gloves must wear after complete gowning.
• Hairs must be covered completely at any part of the body.
• Avoid exposure of body to the area.
• Do not touch floor, wall while and after wearing the garment.
• Minimize the contact of the surfaces with the hand gloves.
• Avoid brisk walking. Follow slow movements.
• Should not make loud/whistle voice.
• Do not laid down on the floor.
• Intimate to the in-charge if any un-comfort and come out the area.
• Record the details provided.

Cleaning and upkeep of sterility testing area :

• This cleaning procedure is applicable for Sterility testing room, Unloading room and Air Lock II.
• The alternate use of disinfectants is recommended at regular interval to prevent proliferation of resistant strain of microorganism.
• Disinfectant and cleaning agent should be freshly prepared. Water for injection or Sterile Purified water should be used for dilution.
• Prepare the required quantity of fresh disinfectant solution by filtered through 0.2µ of Nylon membrane Filtration of Disinfectant should be performed under LAF by connecting the sterile filtration cup direct to sterile collection flask.
• Avoid the chock up of membrane filter by change the membrane filter at specific interval. Record the details of disinfectant preparation in Annexure IV.
• Filtered Disinfectant and 70% IPA should be collected in sterilized bottle and transferred to area for cleaning.
• At first clean the Sterility testing room then follow the cleaning procedure for Unloading room then finally Air Lock III.
• Dedicated lint free mope/broom shall be used for cleaning of sterility testing area.
• Ceiling, Glass panels, doors, LAF bench should be cleaned by Filtered 70% IPA.
• At the start of activity and at the end of activity disinfect the LAF bench with filtered 70% IPA.
• Report the cleaning activity in record as per Annexure II.
• Frequency of cleaning: At the start and end of Activities/Analysis.

Entry procedure for sterility testing area : 

• Before to enter the sterility area, log the entry into ‘Entry and exit record’, refer Annexure I.
• Push the door of Air Lock I and enter into Air lock-I. Disinfect the hands with 70 % IPA / hand sanitiser.
• Remove the footwears in Air Lock I and cross over the bench. Push open the next door and enter into Airlock II. Remove apron and street cloths. Hang it on hangers.
• Open the next door and enter into Air Lock III. Before opening the next door ensure that the previous door is closed.
• Enter the Air Lock III, Sanitize hands with filtered 70% IPA and wear the sterile hand gloves. Take sterile garment pack and perform the gowning procedure.
• For gowning, first wear the head gear, then boiler suit and then wear the booties. At the end wear elbow size sterile hand gloves and sterile goggle.
• At each activity of gowning maintain the hygienic condition and at each activity sanitize the hands with filtered 70% IPA. After complete gowning procedure enter the next area sterility room/unloading room.

Exit procedure from sterility testing room : 

• After completion of work, exit from sterility room/unloading room and enter into Air Lock III.
• Ensuring that doors of respective area are closed completely before opening the other door.
• After enter into the Air Lock III, Perform the degowning procedure i.e fist remove goggle, full size sterile hand gloves, then booties, boiler suit, head gear and at the end removes first hand gloves. Put the used garment and hand gloves in dedicated bin.
• Sanitize the hands with 70 % IPA and exit to Air Lock II.
• Wear the apron and street cloths. Leave the Air Lock II and exit to Air lock I.
• After enter the Air Lock I, Wear the footwear and leave the Airlock I by pulling the door.

 

IV: Annexure :

Annexure I:  Entry and Exit Record for Sterility testing Area.

Annexure II: Cleaning Record of Sterility testing Area

Annexure III:  Reference format for List of Authorized person for entry into sterility testing area

Annexure IV:  Filtered Disinfectant Preparation record

 

 

 

Annexure I

Entry and Exit Record for Sterility testing Area.

 

Month & Year:_____________

Name of Person

Date

Entry Time

Personnel hygienic status

Pressure Differential Status (Limit : 0.6 to 1.6 mm of water)

Cleaning Status

Purpose

Exit Time

Sign

Checked By

Shaving

Hair & nail trimmed

No         ornament

No illness

Air lock I

Air Lock II

Air Lock III

Sterility testing Room

Note: Tick mark ( √ ) indicates satisfactory status.

 

 

 

Annexure II

Cleaning Record of Sterility testing Area

 

       

Date	Disinfectant (Filtered)	Cleaning Status			Ceilings, Walls Doors, Glass pannel, LAF bench by filtered 70%IPA	Done By	Checked By
		Sterility room	Unloading room	Air lock III

Note: Tick mark ( √ ) indicates Cleaning performing status.

 

 

                                                                       Annexure III      

            List of Authorized person for entry into sterility testing area

Sr.No	Name of Person	Designation	Employee Number	Remark
1
2
3
4

Note: Visitors or any other employee of Company must be accompanied by at least one of above mentioned Personnel.

 

	Prepared By	Checked By	Approved By
Name
Designation
Sign/Date

 

 

Annexure IV

Filtered Disinfectant Preparation record

 

Date of Preparation	Name of Disinfectant/Concentration	Total Prepared Volume	Valid Up to	Prepared by	Checked by