environmental monitoring, contamination control

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9/2/2014 SUBMITTED BY, Md. Jaha Sultana, 137NIS0308. SUBMITTED TO, Mr. P. SAIKRISHNA , M.Pharm DEPARTMENT OF PHARMACEUTICS VIJAYA INSTITUTE OF PHARMACEUTICAL SCIENCES FOR WOMEN INTRODUCTION, CONTAMINATION CONTROL, MICROBIAL ENVIRONMENTAL MONITORING

INTRODUCTION:

INTRODUCTION Aseptic processing: The production of sterile drug products by bringing together the product, container and closure that have been subjected to different sterilization methods separately, and assembled them in an extremely high quality environment by skilled personnel using right tools is known as aseptic processing. Aseptic processing area (APA): It is defined as Controlled environments, in which the air supply, materials, equipment and personnel are regulated to control microbial and particulate number to acceptable levels. 9/2/2014

OBJECTIVE OF ASEPTIC PROCESSING:

OBJECTIVE OF ASEPTIC PROCESSING To maintain the sterility of a product assembled from sterile components. To maintain operating conditions so as to prevent microbial contamination. 9/2/2014 Number of aseptic processing contamination problems: Poor personnel practice Loss of environmental control Flawed operational design ASEPTIC PROCESSING CONTAMINATION PROBLEMS

ESSENTIAL ELEMENTS OF ASEPTIC PROCESSING:

ESSENTIAL ELEMENTS OF ASEPTIC PROCESSING 9/2/2014

MICROBIAL ENVIRONMENTAL MONITORING:

MICROBIAL ENVIRONMENTAL MONITORING 9/2/2014

ENVIRONMENTAL MONITORING:

ENVIRONMENTAL MONITORING It describes the processes and activities that need to take place for monitor the quality of the environment. 9/2/2014 CLASSIFICATION OF ENVIRONMENTAL MONITORING Microbiological control Particle control SCOPE Should include monitoring of all environments Should include monitoring of all water

MICROBIAL MONITORING:

MICROBIAL MONITORING Microbial Monitoring is a program designed to demonstrate the control of viable (living microorganisms) and non-viable particles in critical areas.   9/2/2014 SOURCE OF MICROBIAL CONTAMINATION It can come from air, personnel, equipment, cleaning agents, containers, water and compressed gases amongst other things.

WHERE? WHEN? WHAT? WHO? HOW? :

WHERE? WHEN? WHAT? WHO? HOW?

METHODS FOR MICROBIAL MONITORING:

METHODS FOR MICROBIAL MONITORING 9/2/2014

CONTACT PLATE METHOD:

CONTACT PLATE METHOD 9/2/2014

SWABBING METHOD:

SWABBING METHOD 9/2/2014

ACTIVE AIR SAMPLING:

ACTIVE AIR SAMPLING 9/2/2014

PASSIVE AIR SAMPLING:

PASSIVE AIR SAMPLING 9/2/2014

REFERENCE RANGE OF COLONY FORMING UNITS (CFU’S) FOR INTERPRETING RESULTS: :

REFERENCE RANGE OF COLONY FORMING UNITS (CFU’S) FOR INTERPRETING RESULTS: 0 – 5 colonies: none (or) very slight colonies (considered excellent) 6 – 15 colonies: slightly (considered good) 16 - 30 colonies: moderates (borderline acceptable) 31 – 50 colonies: significant (poor) >50 colonies: Heavy(unacceptable) TNTC: To numerous to count(unacceptable)

PARTICLE MONITORING:

PARTICLE MONITORING Particles are significant because they may enter a product and contaminate it physically or, by acting as vehicle for microorganisms, biologically. Particles in the entry air are retained by HEPA filters and particles in the clean room are removed by laminar air stream. HEPA filter are able of retaining of at least 99.97 percent of particulates greater than 0.3 micron in diameter. The regular integrity testing of the HEPA filter is absolutely necessary 9/2/2014

CONTAMINATION CONTROL:

CONTAMINATION CONTROL 9/2/2014

DEFINITION:

DEFINITION Contaminants are in fact the presence of anything in the manufactured product which should not be there. Contaminants can be: Products or substances other than product manufactured Foreign products Particulate matter, especially dangerous in injectables Micro-organisms Endotoxins 9/2/2014

SOURCE OF CONTAMINATION:

SOURCE OF CONTAMINATION People and their activities: Skin Flakes, Hair, Saliva, Clothing Material, Fingerprints, Coughing, Handling, Cosmetics Accessories (tools, equipment): glassware's, trolleys Environmental contaminates: Air, Water, Gases, Chemicals, Vapours, Building Materials, and Electrostatic Discharge. 9/2/2014 CONTAMINATION CONTROL AND ITS RELATIONSHIPS

TYPES OF CONTAMINATION:

TYPES OF CONTAMINATION 9/2/2014

EFFECTS OF CONTAMINATION:

EFFECTS OF CONTAMINATION Contamination posses a significant risk to technical processes, experiments or production activities, as well as to the individuals involved. Unguarded proliferation of contamination can quickly lead to product damage, yield reduction, product recalls and other outcomes highly detrimental to business. 9/2/2014

CONTROL OF CONTAMINATION:

CONTROL OF CONTAMINATION Controlling of contamination from personnel Controlling of contamination from accessories (tools and equipments): Controlling of contamination from environment 9/2/2014

CONTROLLING OF CONTAMINATION FROM PERSONNEL:

CONTROLLING OF CONTAMINATION FROM PERSONNEL Training Education Hoods to cover the hair completely, face masks and plastic boots. Disinfectant soap Goggles Air showers Gowning rooms 9/2/2014

CONTROLLING OF CONTAMINATION FROM ACCESSORIES (TOOLS AND EQUIPMENTS):

CONTROLLING OF CONTAMINATION FROM ACCESSORIES (TOOLS AND EQUIPMENTS) Apart from people, another common way for contamination to enter is on the wheels of trolleys used to transport equipment. To prevent airborne contamination, high-efficiency particulate air (HEPA) filters, airlocks and clean room suits are used. In order to control contaminants from the glassware, the glassware’s are sterilised under suitable conditions with the help of appropriate techniques. 9/2/2014

CONTROLLING OF CONTAMINATION FROM ENVIRONMENT:

CONTROLLING OF CONTAMINATION FROM ENVIRONMENT Complete clean room created with centralized air handling or fan filter units Keeps entire room clean Requires complete gowning, careful materials and equipment selection to maintain class Clean Benches: Horizontal and Vertical Laminar Flow Isolators, Glove boxes provide better protection from outside contamination 9/2/2014

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9/2/2014 Horizontal and Vertical Laminar Flow Glove boxes HEPA filters

CONTAMINATION MEASUREMENT:

CONTAMINATION MEASUREMENT Particulate contamination typically measured with laser particle counter Microbial contamination can be measured in several ways Centrifugal sampler Settle plate method Contact plate method Swabbing 9/2/2014

REQUIREMENTS FOR PREVENTING CONTAMINATION CONTROL:

REQUIREMENTS FOR PREVENTING CONTAMINATION CONTROL Cleaning Cleaning surfaces Vacuuming Wet wiping Cleaning liquids Materials Selection 9/2/2014 General Requirements Minimize sources of contaminants No smoking No cosmetics Avoid high particulate clothing, such as wool sweaters Cover up! Uncovered skin can lead to more contamination  

REFERENCES:

REFERENCES http://en.m.wikipedia.org/wiki/Contamination_control#Function http://contaminationcontrol.dpp-europe.com/spip.php?rubrique103 www.authorstream.com www.slideshare.net www.pharmtech.com www.eajbs.eg.net Remington; The Science and Practice of Pharmacy; 21 st edition; volume-1; page. no: 818 – 819. 9/2/2014

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9/2/2014

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