- Preparation and Usage of Disinfectants
To lay down the procedure for Preparation and Usage of Disinfectants.
This SOP is applicable for Preparation and Usage of Disinfectants used in Microbiology Section of (Pharmaceutical Company Name).
- Microbiologist or above of Microbiology Laboratory: Preparation of SOP.
- Head – Microbiology section / Nominee: Checking of the SOP.
- Head – Quality Control/Nominee: Compliance of SOP
- Abbreviations and Definitions
SOP : Standard operating procedure
No. : Number
QC : Quality Control
QA : Quality Assurance
MLT : Microbial Limit Test
IPA : Iso propyl Alcohol
- Use the dilute disinfectant solutions for different areas as per Tabel-1.
- All the prepared disinfectants used in Sterility Testing areas, MLT and Sub-culture areas shall be filtered through sterile 0.2 µm membrane filter into suitable containers.
- Prepare and filter required volume of disinfectants in purified water or water for injection in MLT area after the completion of work or once the area is available.
- Collect the filtered disinfectant into suitable containers/bottles as per the requirement. Label the disinfectant containers with the details: Name, Date of filtration, filtered by and Use before date and store them in the room. This disinfectant shall be used up to the next day of filtration of the disinfectant.
- For scheduled routine disinfection of floors, walls, and other surfaces prepare the dilute surface disinfectant in the buckets and use immediately.
- For surface disinfectant used during other activities, prepare and add the disinfectant in the spray bottles. Label these dilute disinfectant bottles with the details: Name, Date of preparation, Preparation number, prepared by and Use before Date. This disinfectant shall be used up to the next day of preparation of the fresh disinfectant.
- For LAF workbenches use 70% IPA for cleaning and disinfection.
- Use the sterillium as it is without dilution.
- Use the defined volume of disinfectants concentration solutions and diluent as per Table-2, for 1000 ml of dilute disinfectant preparation.
- Record the preparation of disinfectants as per Annexure no.
Table-1: Disinfectants to be used and their applications
|Name of disinfectant||Concentration||Areas||Application|
|Virosil||20%||Sterility testing, MLT, Sub-culturing areas||For fogging|
|Triple 100||1%||Sterility testing, MLT, Sub-culturing areas||Surface disinfectant for floors, walls, equipments, working tables etc.|
|Combatan DS||1%||Sterility testing, MLT, Sub-culturing areas||Surface disinfectant for floors, walls, equipments, working tables etc.|
|Protasan DS||1%||Sterility testing, MLT, Sub-culturing areas||Surface disinfectant for floors, walls, equipments, working tables etc.|
|Iso Propyl Alcohol (IPA)||70%||MLT, Sub-culturing areas and other non-critical areas and LAF workbenches.||Surface and hand disinfectant in areas where, expected bioburden is low.|
|Lyzol||2.5%||Areas of Microbiology Laboratory excluding testing areas||Surface disinfectant for floors, walls, equipments, working tables etc.|
|Domex||2.5%||Areas of Microbiology Laboratory excluding testing areas.||Surface disinfectant for floors, walls, equipments, working tables etc.|
|Savlon||2.5%||Areas of Microbiology Laboratory excluding testing areas.||Surface disinfectant for floors, walls, equipments, working tables etc.|
|Cidex||Undiluted||Sterility testing, MLT, Sub-culturing areas||Surface disinfectant for floors, walls, equipments, working tables etc. (Use by spraying)|
|Sterillium||Undiluted||Sterility testing area||Hand disinfectant|
Table-2: Composition of Dilute disinfectants for 1000 ml preparation
|Name of disinfectant||Vol. of conc. Disin.||Volume of diluent||Concentration|
|Triple 100||10 mL||990 mL||1%|
|Combatan DS||10 mL||990 mL||1%|
|Protasan DS||10 mL||990 mL||1%|
|Iso Propyl Alcohol||700 mL||300 mL||70%|
|Lyzol||25 mL||990 mL||2.5%|
|Domex||25 mL||975 mL||2.5%|
Volume of Disinfectant concentration. Volume of dilute disinfectant.
Forms and Records (Annexures)
- Dilute Disinfectant Preparation Record
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
Reason for Revision
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During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube