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plant layout, maintenance and sanitation for pharmaceutical premises

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PREMISES : PLANT LAYOUT, MAINTENANCE & SANITATION:

CREATED BY: Ravi Mistry M.Pharm. QARA 2 nd Sem L. J. Institute Of Pharmacy, Ahmedabad PREMISES : PLANT LAYOUT, MAINTENANCE & SANITATION GUIDED BY: Mr. Manish Bachani Assistant Professor Department Of QARA

CONTENT:

Introduction Plant Layout Types Of Plant Layout Factor Influence On Plant Layout Maintenance Sanitation References CONTENT

INTRODUCTION:

PRINCIPLE : Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. INTRODUCTION

CONTI…:

GENERAL : Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products. Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures. CONTI…

CONTI…:

Lighting, temperature, humidity and ventilation should be appropriate. Premises should be designed and equipped so as to afford maximum protection against the entry of the insects or other animals. Steps should be taken in order to prevent the entry of unauthorized people. Production, storage, and quality control areas should not be used as a right of way by personnel who do not work in them. CONTI…

PLANT LAYOUT:

Plant layout refers to the arrangement of physical facilities such as machinery, equipment, furniture etc. with in the factory building in such a manner so as to have quickest flow of material at the lowest cost & with the least amount of handling in processing the product from the receipt of material to the shipment of the finished product. PLANT LAYOUT

PLANT LAYOUT:

IMPORATANCE: An ideal plant layout should provide the optimum relationship among output, floor area & manufacturing process. It allows flexibility of operations, easy production flow, makes economic use of the building, promotes effective utilization of manpower, & provides for employee’s convenience, safety, comfort at work, maximum exposure to natural light & ventilation PLANT LAYOUT

ESSENTIALS:

An efficient plant layout is achieved by the following objectives: Proper & efficient utilization of available floor space To ensure that work proceeds from one point to another point without any delay. Provide enough production capacity. Reduce material handling costs. Reduce hazards to personnel. Utilise labour efficiently. Increase employee morale. Provide for volume & product flexibility. Reduce accidents. Provide for employee safety & health. Allow ease of maintenance. Allow high machine or equipment utilization. Improve productivity. ESSENTIALS

ADVANTAGES OF PLANT LAYOUT:

To the worker: There are lesser number of operation and material handling. There is reduction in length of hauls and motions between operations, which minimize production time as well as the activities of workers. There is more labor productivity i.e. more output per man hour. There is more safety and security to workers from accidents. Better working conditions resulting in improved efficiency. In manufacturing costs: Maintenance and replacement costs are reduced. Loss due to waste and spoilage is minimized. Improved quality of product . Better cost control. ADVANTAGES OF PLANT LAYOUT

ADVANTAGES OF PLANT LAYOUT:

In production control and supervision: It provides more space for production operation. There is efficient arrangement for receipt, transportation, and delivery of raw material and finished goods. There is a better and convenient storage facility. Control and supervision operations are provided at appropriate points. ADVANTAGES OF PLANT LAYOUT

FEATURES OF A GOOD LAYOUT:

There should be sufficient space for the workers as well as for the equipment to perform their functions. This will ensure smooth and continuous flow of production process. It must provide adequate safety and security to workers against accidents or injury. For example, provision of fire fighting equipment, first aid boxes, etc. The arrangement of machines and equipment should be such that minimum material handling is necessary for low cost processing. The store for material should be such that minimum material handling is necessary for low cost processing. FEATURES OF A GOOD LAYOUT

SAMPLE LAYOUT OF A PHARMACEUTICAL FACTORY:

Good cGMP Design Features Include: Clear layouts Appropriate detailing and finishes Adequate room sizes and staging areas Flexibility Able to adapt to different uses Able to bring new services to the rooms Ease off clean up SAMPLE LAYOUT OF A PHARMACEUTICAL FACTORY

SAMPLE LAYOUT OF A PRODUCTION DEPARTMENT:

SAMPLE LAYOUT OF A PRODUCTION DEPARTMENT

SAMPLE LAYOUT OF F&D DEPARTMENT:

SAMPLE LAYOUT OF F&D DEPARTMENT

TYPES OF PLANT LAYOUT :

There are 3 types: Manufacturing units. Traders. Service Establishments. 1) Manufacturing units a) Product or line layout: Under this, machines and equipments are arranged in one line depending upon the sequence of operations required for the product Ex: manufacture of tablet ; dispensing. Powder blending, granulation, drying. Advantage: Processing work is quick and smooth Manufacturing time is reduced and cycle can be speedup Cost of material handling can be reduced. TYPES OF PLANT LAYOUT

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b) Process layout: In this type of layout machines of a similar type are arranged together at one place. EX : All cutting machine may be placed at one department. Advantage: More supervision can be achieved Disruption of production is less Specialized work can be provided c) Fixed position or location layout: The major product being produced is fixed at one location. Equipment labour and components are moved to that location. All facilities are brought and arranged around one work center. d) Combined or group layout Certain manufacturing units may required all three processes namely intermittent process (job shops), the continuous process (mass production shops) and the representative process combined process (i.e. miscellaneous shops)

FACTOR INFLUENCE ON PLANT LAYOUT:

Raw material Market for product Energy availability Transportation facilities Labour supply Water supply Waste disposal FACTOR INFLUENCE ON PLANT LAYOUT

MAINTENANCE:

(USFDA GUIDELINES) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. Deterioration of buildings not only presents a poor image of the facility, it can also impact on product quality. 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. MAINTENANCE

CONTI…:

Floor cracks can also become a safety hazard for people or even dislodge materials from trucks. 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. CONTI…

SANITATION:

(USFDA GUIDELINES) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition. 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. There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents and cleaning and sanitizing agents. SANITATION

CONTI…:

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. 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. Cleaning procedures should be written in sufficient detail with respect to materials, equipment, process, and frequency that they are unambiguous. CONTI…

OBJECTIVES OF SENITATION ARE::

Removal of dirt and other waste material; Minimize the risk of cross contamination between different products in the same area; Reduce the number of micro-organisms in work area; Control pests so that these do not affect the quality of materials to be used in the manufacture of drugs. For protection of premises from outside environment, some important measures are: Effectively seal manufacturing plant from outside environment by :- Avoiding multiple entry/ exit positions, Providing air-lock at each entry point OBJECTIVES OF SENITATION ARE:

CONTI…:

Install insectocutors at effective positions like main entrances, entrances to manufacturing areas including packaging section, inside manufacturing areas. Carry out pest control periodically. Services of pest control agency can be availed for this purpose. sanitation in manufacturing areas is more important than other areas because of risk of contamination is more in these areas, protection from outside environment too is necessary. CONTI…

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CLEANING AGENTS AND DISINFECTANTS

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Disinfectants destroy pathogenic and other micro organisms and are used to reduce microbial count in manufacturing area. Commonly used disinfectants their chemical nature and uses are given here under: CLEANING AGENTS AND DISINFECTANTS

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Typical cleaning schedule for tablet manufacturing areas are given below. Similar schedules can be prepared for other manufacturing areas. CLEANING AGENTS AND DISINFECTANTS

REFERENCES:

GMP for Pharmaceuticals, A Plan for total quality control, Sidney H. Willig , James R. Stoker, 4th edition , Marcel decker Inc. Page no. 43-61 How to practice GMPs A guide for cGMP compliannce along with PAT & HACCP by P.P. Sharma;vandana publication fifth edition pg no 128-152 cGMP current good manufacturing practices for pharmaceutics by Manohar A. Potdar by published Pharma med press pg no45-76 Pharmaceutical manegment By CVS Subharamanyam By vallabh publication First Edition on 2012 pg no 20-28 REFERENCES

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A BIG THANK YOU…

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