Preparation Filtration Usage and Destruction of Disinfectant Solution

1.0. OBJECTIVE :
1.1 To lay down a procedure for Preparation , Filtration ,Usage and destruction of Disinfectant Solution.
2.0 SCOPE :
2.1 This procedure is applicable for Preparation , Filtration ,Usage and destruction of Disinfectant Solution in Injection (Parenteral) at …….
3.0 RESPONSIBILITY :
3.1 Officer/Executive Production
4.0 ACCOUNTABILITY :
4.1 Head of Department
5.0 PROCEDURE :
5.1 DISINFECTANT PREPARATION
5.1.1 Different disinfectant solution to be prepared alternatively for Cleaning/Sanitization of sterile area employees

carrying out this job to be periodically trained.
5.1.2 Select suitable disinfectant from the given chart and make the disinfectant solution as per requirement.
5.1.3 Ensure the cleaning of pressure vessels before the disinfectant preparation.
5.1.4 Ensure the validity of disinfectant before the disinfectant prepration.

S. No.	Name of Solution	Concentration	Quantity in mL	Quantity WFI in mL	Disnfectant Solution in mL
1.	Acitar in (2% w/v glutaraldehyde , 5% w/v Benzalkonium chloride solution IP)	5 %	50	950	1000
2.	Totasep in[3% w/v poly (hexamethylenebiguanide) hydrochloride 10% w/v Didecyl dimethyl ammonium Chloride]	2.5 %	25	975	1000
3.	Silvicide (0.1 % w/v silver nitrate 10 % w/v hydrogen peroxide)	5 %	50	950	1000

5.1.5 Prepare 70% Isopropyl Alcohol solution as fast Alcohol base disinfectant for hand gloves.
5.1.6 After preparation filter this solution through 0.2µ Hydrophilic/Hydrophobic filter.
5.1.7 Dispense it in suitable glass/SS container .
5.1.8 Disinfectant shall be rotated as per scheduled mentioned below

S. No.	Rotation Period	Name of Solution
1.	From date 1^st to 10^th of month	Acitar (5.0 %V/V)
2.	From date 11^st to 20^th of month	Totasep (2.5 %V/V )
3.	From date 21^st to end of the month	Silvicide (5.0 %V/V)

5.2 FILTRATION:
5.2.1 Check Filtration LAF is “ON” and magnehelic Gauge reading is within the limit.
5.2.2 Place the Sterilized membrane under LAF.
5.2.3 Connect the outlet of Disinfectant Filter to the inlet of Disinfectant holding vessel(Filtration vessel).
5.2.4 Connect inlet of Disinfectant Preparation vessel to Nitrogen Supply line.
5.2.5 Open the regulate the Nitrogen pressure through pressure regulator gradually to achieve a pressure of 1.0 to 2.0 Kg/cm².
5.2.6 Allow the solution to pass through the 0.2µ filter and collect solution in Sterilized filtration Vessel.
5.2.7 After complete solution has been filtered close Nitrogen supply valve.
5.2.8 Disconnect all silicone tubes and transfer them to equipment washing area for cleaning .

5.3 USAGE:
5.3.1 For Aseptic area Filtered disinfectant solution is used and prepare only required quantity of disinfectant solution and store in Sterilized container and keep under LAF.
5.3.2 For Non Aseptic area unfiltered disinfectant solution is used and prepares only required quantity.
5.3.3 Destroy the unused quantity at the end of the day, if applicable.

Sr.No.	Abbreviation used	Full form of abbreviation used
1.	SOP	Standard Operating Procedure
2.	WFI	Water For Injection
3.	%	Percentage
4.	IPA	Iso Propyl Alcohol
5.	Ltd	Limited
6.	mL	milliliter
7.	SS	Stainless steel
8.	QA	Quality Assurance

Sr. No.	Reference Title
1.	In-house

Preparation Filtration Usage and Destruction of Disinfectant Solution

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