MAINTENANCE AND SANITATION in PHARMACEUTICAL INDUSTRY

MAINTENANCE & SANITATION IN PHARMACEUTICAL INDUSTRIES: 

MAINTENANCE & SANITATION IN PHARMACEUTICAL INDUSTRIES Presented By: K. Anupama M. Pharm [Q.A], 1 st Sem Gyan Vihar School of Pharmacy S.G.V.U, Jaipur

MAINTENANCE: 

MAINTENANCE Maintenance , literally means ‘The Process or Practice of keeping something in good condition’. In pharmaceutical industries as per various regulatory bodies maintenance says - “Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair”.

Deficiencies in maintenance :: 

Deficiencies in maintenance : The most important lacunas or illegibility or deficiencies that should be avoided in industries are : Buildings under deterioration state Cracks and holes on walls , floors and ceilings. Deep floor cracks Ingress of water from roof leaks Holes in roofs or top of buildings Damage to insulation or pipes Light fittings Improper building inspection and maintenance programs.

The impacts of these deficiencies;: 

The impacts of these deficiencies; Buildings under deterioration state: Deterioration of buildings not only presents a poor image of the facility, it can also impact on product quality. Cracks and holes on walls, floors and ceilings: Cracks and holes in walls, floors, or ceilings can provide access for insects, rodents, birds, dirt, or microorganisms. They can also hinder cleaning and sanitation, thereby increasing the potential for cross contamination or microbial multiplication.

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Deep floor cracks: Floor cracks can also become a safety hazard for people or even dislodge materials from trucks. Ingress of water from roof leaks: The ingress of water from roof leaks can cause significant damage to materials and equipment, give rise to electrical failures and fires and result in damage to the basic structure of the building. Holes in roofs or top of buildings: holes in the roof or near the tops of buildings provide ready access to birds, which may then be encouraged to nest within the building.

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Damage to insulation or pipes: Damage to insulation or pipes and duct work will detract from the basic purpose of such insulation. It may also result in freezing and eventual leakage of pipes and in the shedding of insulation material into product and equipment. Light fittings: Light fittings need regular cleaning to remove any accumulated dust, which can act both as a potential source of contamination and reduce light intensity.

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Improper building inspection and maintenance programs: Building inspection and maintenance programs should be defined in writing and a record kept confirming compliance and referencing any repairs performed. Where the proper correction of building deficiencies requires shut-down of the area, it may be necessary to resort to temporary repair until adequate time can be made to enact a permanent repair. Clearly services can impact directly on processing and product quality and they must undergo routine maintenance. Essential services will include HVAC, water(all types), steam, vacuum, compressed air and other gases, electricity, dust extraction, product/material pipelines, drainage and sprinkler system.

Importance of proper maintenance: 

Importance of proper maintenance Avoidance of contamination. Good product quality can be obtained. Accidents can be avoided. Systematic and smooth functioning of the industry. Safety can be enhanced.

Objectives of sanitation: 

Objectives of sanitation Objectives of sanitation are: Removal of dust, dirt and other waste materials; Minimize the risk of contamination between different products in the same area; Reduce the number of micro-organisms in work areas Control pests so that these do not affect the quality of materials to be used in the manufacture of drugs.

SANITATION: 

Meaning ‘ the arrangements for protecting health esp. drainage’. As per GMP guidelines, Sanitation says; “Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition”. SANITATION

GMP GUIDELINES FOR PROPER SANITATION: 

GMP GUIDELINES FOR PROPER SANITATION There are various GMP guidelines for proper sanitation in pharmaceutical industries and they are as follows ; Building shall be free of infestation by rodents, birds, insects and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner. There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.

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There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135). Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations.

PROPER SANITATION PRACTICES : 

PROPER SANITATION PRACTICES This requirement relates to the availability of effective cleaning and sanitation programs and confirmation that they have been followed. Cleaning and sanitation programs should be adjusted to meet the specific needs of each facility. In addition to the cleaning of floors, walls, and ceilings, there should be attention to dust extraction and air input systems. Duct work, especially for dust extraction systems, can become a potential explosion hazard if dust is allowed to accumulate.

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Cleaning procedures should be written in sufficient detail with respect to materials, equipment, process, and frequency that they are unambiguous. Appropriate, data should be accumulated to confirm the adequacy of the cleaning procedure. The total elimination of rodents, birds, and insects is virtually impossible and the regulations do refer to freedom from ‘‘infestation.’’ The use of rodenticides, fungicides, fumigating agents, and other techniques should be combined with good hygienic practices.

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Spilled materials, such as sugar, that might attract creatures should immediately be eliminated. Holes in buildings that could provide additional means of access should be blocked. Where traps and other lethal techniques are used, there should be frequent examination and removal of ‘‘corpses,’’ which could in time become a source of further contamination. If these traps consistently yield results, attempts should be made to identify and eliminate the source of the problem. Frequently, rodenticide and other treatments are contracted out. As with any contracted service, the company must assure that the procedures used are viable, achieve the desired results, and that they are followed.

Important measures for protection of premises from outside environment: 

Important measures for protection of premises from outside environment Effectively seal manufacturing plant from outside environment by: Avoiding multiple entry/exit positions Installing ‘air curtain’ at each main entrance; Providing air-lock at each entry point. Install insectocutors at effective positions like main entrances, entrances to manufacturing areas including packaging sections, inside manufacturing areas. Keep surroundings of the building clean. Maintenance of lawn will keep incidence of dust flow.

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Carry out pest control periodically. Services of pest control agency can be availed for this purpose. Anti-insects paints from Artillin* for interiors and exteriors can also be used.

Cleaning methods: 

Cleaning methods Common cleaning equipments used for physical removal of dust and dirt are vacuum cleaners, brooms, brushes, floor mops, sponges and jet cleaners. Cleaning agents help to remove extraneous material from surfaces. Some of the commonly used cleaning agents, their chemical nature, concentrations in which these are used and their uses are given in the following table:

Cleaning agents used are:: 

Cleaning agents used are: Name of the cleaning agent Active ingredients Concentration Uses Teepol Sodium benzene sulphate , alcohol ether sulphate and alcohol ethoxylate 0.1 % Multipurpose cleaning agent, can be used for equipment, floors, glasswares Avipol Liquid detergent of the sodium alkyl sulphate type 1% Tanks and vessels in liquid oral manufacturing. Liquid soap Soap ‘as is’ Can be used for washing hands gloves, machine parts. Vim Mixture of detergents ‘as is’ Toilets, floors, sinks

Disinfectants used:: 

Disinfectants used: Disinfectants destroy pathogenic and other microorganisms and are used to reduce the microbial count in the manufacturing area. Commonly used disinfectants, their chemical nature and uses are given here under: Name of the disinfectant Active ingredients Uses Savlon Chlorhexidine gluconate and cetrimide 2.5% solution can be used for treating all surfaces in aseptic area. Dettol Chlorxylenol and terpineol 2.5% solution can be used for hands & spray Fairgenol Dichlormetaxylenol , terpineol & soap 2.5% solution can be used for treating all surfaces in aseptic area.

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Name of the disinfectant Active ingredients Uses Isopropyl alcohol Alcohol 70% solution can be used for the treatment of equipment and work surfaces Hypochlorite solution Sodium hypochlorite Useful in treatment of cleaned vessels in liquid mfg., conc 0.1- 1% Formalin Formaldehyde A mixture of potassium permanganate & Formalin is used for disinfection of sterile areas Contd.

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It is advisable to use these disinfectants on a rotation basis with predetermined periodicity. For sterile areas the periodicity of change of disinfectants should be of higher frequency like change on alternate days . Presence of other matter interferes with disinfection of chemical agents. For e.g. Grease can give physical protection to microorganisms. Disinfecting action of the agent is not possible until it penetrates the grease. Some matter may act as nutrients for microbes. However, this may act in one of the two directions: allowing undesirable multiplication; bringing organisms to an actively mitosing condition at which they are more vulnerable to attack. Some organic compounds can reduce disinfecting action by adsorbing sanitization agent.

Cleaning Schedules: 

Cleaning Schedules Typical cleaning schedules for tablets and liquid oral manufacturing areas are given below. Similar schedules can be prepared for other manufacturing areas.

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Cleaning Schedules for Tablet manufacturing section Area Frequency Method of cleaning Floors Minimum once a day Cleaning with broom or vacuum cleaning & damp mop with disinfectant. Walls Daily Twice Vacuum cleaning Jet wash & damp mop Ceiling Weekly Vacuum cleaning Windows Daily Vacuum cleaning & dry mop Exhaust fans Weekly Dry mop & then wet mop with disinfectant Light fixtures , ducts of air conditioning Weekly Vacuum cleaning Equipment Daily Scrubbing, jet washing & washing area disinfection with disinfectant

Cleaning schedule for Liquid Oral Manufacturing Section: 

Cleaning schedule for Liquid Oral Manufacturing Section Area Frequency Method of cleaning Floors 1-2 times/day Washing using scrubber and hose of water, damp mop with disinfectants Platforms Daily Cleaning of surface with scrubber & water, mop with disinfectant Handrails & stairways( if entry to section is through stairs) Daily Dry mopping and then wiping with disinfectant solution Walls Twice a week Cleaning with scrubber and hose of water Sinks & washing areas Daily Scrubbing using cleaning powder, washing & disinfection Doors, Windows Fixtures, Ducts etc Weekly Fortnightly Vacuum Cleaning Vacuum cleaning, wet moping of windows, glass, doors with disinfectant solution, damp moping of other fixtures using 0.1% teepol solution.

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Area Frequency Method of cleaning Sinks and washing area Daily Scrubbing using cleaning powder, washing and disinfection Doors, Washing fixtures, ducts etc Weekly Fortnighly Vacuum cleaning Vacuum cleaning, wet moping of windows , glass doors with disinfectant solution , damp moping of other fixtures using 0.1% teepol solution. Ceiling Monthly Cleaning with 0.1% solution of detergent with hose of water, if ceiling is not dirty vacuum cleaning may be done. Shelves( for materials, small containers, storage of tools etc) Weekly Vacuum cleaning, damp wipe using disinfectant solution Contd.

Records of Sanitation: 

Records of Sanitation Records of sanitation should be maintained. Records can be maintained in the form of log-book. A separate log-book can be maintained for each section. Format of log book is given here under; LOG BOOK FOR SANITATION Work Area…………………………………………… Date Code* No. of SOP for sanitation Sign of person Who executed the job Responsible for the job

Other measures which should be taken to maintain sanitation in manufacturing areas are: : 

Other measures which should be taken to maintain sanitation in manufacturing areas are: Regular pest control programme should be drawn up for stores, manufacturing and packaging areas. Services of a pest control agency may be employed. Manufacturing areas should not be used for other than manufacturing purposes. Eating, chewing or smoking should not be allowed in manufacturing areas. Manufacturing areas should not be used as general thoroughfare for personnel nor should be these used for storage of materials except for materials to be processed there.

Importance of Sanitation: 

Importance of Sanitation Prevents contamination of products. Cross- contamination can be avoided. Health and safety of the workers can be taken care of. Improves product quality.

REFERENCES:: 

REFERENCES: How to practice GMPs; P.P. Sharma; 5 th edition;Page no. 53-59. ICH Guidelines

THANK YOU: 

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