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SOP for cleaning and sanitization of controlled area

  • Objective:
  • To lay down a procedure for cleaning and sanitization of controlled area.
  • Scope:
  • This SOP is applicable for cleaning and sanitization of controlled area.
  • Responsibility:
  • Production Officer / Executive.
  • Accountability:
  • Production Head shall be accountable for compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • S.S. : Stainless Steel
  • Procedure:
  • Following are the areas considered as Controlled area: garment washing room, de-cartoning room, vial washing and sterilization room, Wash equipment area, vial sealing room, personnel air lock I & material air lock.
  • Disinfectant solution shall be used as per sanitization schedule and attached with SOP Annexure -1.
  • Cleaning is carried out after completion of day production work or whenever necessary with purified water.
  • Clean all equipment and LAF as per respective SOP with purified water.
  • Collect glass vials, rubber stopper and seals etc. from floor with the help of rubber blade mopper if any.
  • Clean the floor daily with mop soaked in purified water.
  • Sanitize the floor daily with mop soaked in disinfectant solution.
  • Clean and sanitize the drain daily as per SOP on sanitization of drains.
  • Clean and sanitize the wall panel and return air riser every week and at the product change over with mop soaked in disinfectant solution.
  • Clean and sanitize ceiling panels, wall panels, doors, windows, view panels, glasses, tube light fittings and electrical switches every week with lint free duster soaked in disinfectant solution.
  • Fill the cleaning and sanitization record as per Annexure-2, and get the cleaning checked by concerned supervisor / officer.

Annexure-1

Sanitization schedule

Disinfectant shall be used in rotation on weekly basis as per following table: –

Sr. No. Name of the disinfectant Active other ingredients Dilution to be used Quantity of disinfectant taken(ml) Quantity of solvent (water for injection) taken(ml)
1.0 Disinfectant for controlled area
1.1 Protasan Benzal konium chloride 11.50%

Non ionic surfactants

1% v/v 100 ml 10000 ml
1.2 Triple – 100 Ortho phenyl phenol

Ortho Benzyl chloro phenol  10%

Para Tertiary amyl phenol

1% v/v 100 ml 10000 ml
1.3 Combatan DS Benzalkonium chloride 10%

Biguanide hydrochloride 12%

Formaldehyde 15% Ethane dialdehyde 30%

Non ionic surfactant qs

Milder qs

1% v/v 100 ml 10000 ml
1.4 IPA isopropyl alcohol 70 % v/v 3500 ml 5000 ml

 

Annexure-2

Cleaning and sanitization of controlled area

Preparation of disinfectant solution: –                                                     Date: ……………………

Disinfectant Concentration Qty. Qty. of WFI for Dilution in Ltrs. Total qty. of solution

Prepared

Prepared By Checked By
Triple 100 (1%)
Protasan DS (1%)
Combatan DS (1%)
Isopropyl Alcohol (70%)

 

Disinfectant used: –                                                                                     Date: ……………………

Area Cleaning done By Sanitization done By Checked By
Vial de-cartoning room
Vial washing and sterilization room
Garment washing room
Equipment washing and sterilization room
Personnel air lock & Material air lock
Vial sealing room & sealing air lock
Ceiling panels, wall panels, doors, windows, view panels, glasses, tube light fittings and electrical switches (Weekly)
Return air riser, grill and pendants
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies – Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision

     

    00 New SOP

     

 

 

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