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.

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: –

Protasan : Benzalkonium chloride 11.50% , Non ionic surfactants ,Dilution to be used – 1% v/v.

Triple – 100 : Ortho phenyl phenol ,Ortho Benzylchloro phenol  10% ,Para Tertiary amyl phenol ,Dilution to be used – 1% v/v.

Combatan DS :

Benzalkonium chloride 10%

Biguanide hydrochloride 12%

Formaldehyde 15% Ethane dialdehyde 30%

Non ionic surfactant qs

Milder qs

Dilution to be used – 1% v/v.

Isopropyl alcohol -70 % v/v Dilution to be used – 1% v/v.

Annexure-2

Cleaning and sanitization of controlled area

Preparation of disinfectant solution/Date

  • Triple 100 (1%)
  • Protasan DS (1%)
  • Combatan DS (1%)
  • Isopropyl Alcohol (70%)

Disinfectant used/Date

  • Vial de-cartooning 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

About Pharma Editor

Check Also

PROCESS VALIDATION PROTOCOL OF TACROLIMUS CAPSULES

PROCESS VALIDATION PROTOCOL  TACROLIMUS CAPSULES Tacrolimus is administered in conjunction with other medications to inhibit …