The document discusses guidelines for sanitation and cleaning of aseptic areas for pharmaceutical production. It outlines standard operating procedures for cleaning, including materials used, frequencies, equipment, and record keeping. Monitoring of disinfectants and clean areas is recommended to control microorganisms and ensure environments remain within specifications. Personnel activities and item transport into clean rooms should maintain suitable cleanliness standards. Disinfectant efficacy should be assessed through an environmental monitoring program.

1. ‘’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

2. Introduction
Objectives
WHO Guidelines
MCC Guidelines
Validation
References
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3. • 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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4. • 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 be7/13/2015 4

5. • 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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6. • 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
Respon
si-ble
for the
job
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7. Name Of
Disinfectant
Active
Ingredients
Conc. Use
Teepol Sodium
Benzene,Sulpho
nate 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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8. • 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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9. • 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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10. • 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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11. • 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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12. • 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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13. • 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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14. • 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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15. 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.13.23-24.7/13/2015 15

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