Sterile Pharmaceutical Products

‘’SANITATION’’

N.D.M.V.P. Samaj’s College of Pharmacy,

Gangapur Road, Nasik – 422 002 (2014-2015)

presented by:- Nitin P. Kanwale Roll No. 06 M.Pharm. 1st Sem. (Q.A.T.) Sub. Teacher:- M.S. Sonawane

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Content:-

IntroductionObjectivesWHO GuidelinesMCC GuidelinesValidationReferences

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Sanitation:• Sanitation is the maintaining of

cleanliness of aseptic production areas and other clean rooms By using appropriate conc. And frequency of disinfectant.

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OBJECTIVES:[1]

• Removal of dust and other waste material. •Minimize the risk of cross contamination between different products in same area.• Reduce the number of microorganism in work areas.• Control pests so that these do not affect the quality of materials to be used in manufacture of drugs.

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WHO Guidelines:[2]

• The sanitation of clean areas is particularly important. They should be cleaned frequently and thoroughly in accordance with a written programme approved by the quality control department.

• SOPs For cleaning and sanitation mainly includes:[3]

Materials used like, detergents, disinfectants and their concentrations. Frequency of cleaning. Equipment and accessories used. Methods of cleaning and sanitation.

List of trained peoples and supervisor. Performance evaluation(microbial where needed) and certification. Records of cleaning and sanitation activities performed.

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• LOG-BOOK For Sanitation :-[3]

Work-Area :____________

• Where disinfectant are used , more than one type should be employed, with periodic alterations.

• Monitoring should be regularly undertaken in order to detect the emergence of resistant strains of microorganisms.

• In view of its limited effectiveness, ultraviolet light should not be used as a substitute for chemical disinfection

Date:- Code* No. of SOP for Sanitation

Sign. Of Person

Who execuated the job

Responsi-ble for the job

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Some Used Disinfectant:-

Name Of Disinfectant

Active Ingredients

Conc. Use

Teepol Sodium Benzene,Sulphonate Alcohol,

0.1% Multipurpose Agent Cleaning of glasswares And Floors

Savlon Chlorhexidine Gluconate And Cetrimide

2.5% Floors,surface

Formalin Formaldehyde 40% All Sterile Areas

Liquid Soap Soap As Is Hands,gloves

Vim Mixture Of Disinfectants

AS Is Machine Parts

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• Disinfectant and detergents should be monitored for microbial contamination. Dilution should be kept in previously cleaned containers and should not be stored for long periods unless sterilized. • Clean areas should be monitored at

planned intervals during operations by means of microbial counts of air and surfaces, where aseptic operations are performed, monitoring should be frequent to ensure that the environment is within specification.

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• The results of monitoring should be considered when batches are assessed for approval.• Air particulate quality should also be

evaluated on a regular basis. • Additional monitoring is sometimes

desirable even when there are no production operations, e.g., after validation of system , cleaning and fumigation.

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MCC South Africa Guidelines:[2]

• Clean rooms and related areas should be monitored at planned intervals for microbiological contamination using a combination of “setting plates”, surfaces sampling and air sampling and the results obtained should be used to determine “warning”, “action” and “shut-down” levels.

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• Personnel conducting filling operations should not be used exchanged during a shift with employees performing other functions within the aseptic preparation area.• Operators working in non-sterile

support areas shall not have access to the critical processing zone.• Micro-organism recovered from clean

room should be routinely identified, at least , at least to genus level.

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• Items into clean room, including means of transport, should be of a standard of cleanliness compatible with the environmental standard for the room.• The absence of disinfectant and cleaning agent residuals 0n contact surfaces shall be confirmed.• The manufacturers instruction should be followed with respect to storage and use.

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• Disinfectant shall be batched with a stated expiration date, and containers should not be refilled. • Interchanging or rotating disinfectant

should be reconsidered due to potential changes in environmental flora.• A sporicidal agent may be necessary

when environmental monitoring indicates the presence of spore forming organism or fungi.

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Validation of Disinfection Procedures:[4]

• The reliability and frequency of disinfection procedures should be established through an environmental monitoring program.

• Disinfectants should be microbiologically assessed prior to use in each facility, and appropriate control procedures should also be instituted for each facility.

• The efficacy of disinfectants should be assessed with respect to ensuring that microorganism counts remain below the count predetermined based on the type and count of isolates collected from various surfaces through the environmental monitoring program.

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References:-1. Sharma PP. How to practice GMPs, A plan For total

Quality Control. 2nd ed. Agra: Vandana Publication; 1994. P.140.

2. Potdar MA. cGMP for Pharmaceuticals. pharmaMed Press. Hyderabad; 2012.P.638-43.

3. Sample:- Standard Operating Procedure. Pdf.4. Muroi M, Yoshimi U, Tsugao S, et al. Guidelines on the

Manufacturing of sterile Pharmaceuticals Products By Aseptic Processing. 1st ed. July 2016. P. 17-25.

5. Iyer S. Guidelines On cGMP And Quality Of Pharmaceuticals Products. 1st ed. ; Mumbai: DK Publication; Jan 2013. P.59.

6. Potdar MA. Pharmaceutical Quality Assurance. 2nd ed. Pune: Nirali Prakashan; 2007. P.13.23-24.

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