SOP for cleaning and sanitization of controlled area

Pharma Editor November 23, 2016 Production Comments Off on SOP for cleaning and sanitization of controlled area 9,036 Views

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

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