LAYOUT AND DESIGN OF FACILITIES & MATERIAL FLOW

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LAYOUT AND DESIGN OF FACILITIES & MATERIAL FLOW

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LAYOUT AND DESIGN OF FACILITIES & MATERIAL FLOW:

LAYOUT AND DESIGN OF FACILITIES & MATERIAL FLOW Presented By: Sumit Kumar Mittal M.Pharma (II Sem ) Department of Quality Assurance I.S.F College of Pharmacy, Moga (Punjab) 1

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(A) Layout of the facilities (B) Control of cross contamination (C) Humidity/temperature controls (D) Water systems (E) Plant pest control 2

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(A) Layout of the facilities : (Material Flow) The overall facility as well as the individual process areas should always take into consideration the most simplistic route of material flow and the control of cross contamination. The prime objective at all stages of inventory is to separate released materials from quarantined or rejected materials. The 3 typical layouts for pharmaceutical manufacturing are as follows : Perimeter manufacturing, center warehouse. Circular flow. Straight line flow. 3

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It is one of the more popular solid-dosage form layouts. It involves the following : The center of the facility is a storage of warehouse area for raw materials, packaging components and bulk stocks, with the manufacturing and packaging operations located at the outer perimeter. Flow of raw materials : Receiving and approved dispensing manufacturing Quarantine areas storage area packaging tablets in quarantine bulk stock Packaging is scheduled tablets and packaging component delivered from bulk stock and approved storage areas 4

Advantage ::

Advantage : It has the advantage of space conservation by virtue of having the supply areas close to the areas being supplied. Disadvantage : A significant disadvantage is the crossover traffic pattern of materials , with the ensuing potential for contamination or mix-up. 5

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Receiving area, Approved raw materials, & Component storage. Manufacturing, Quarantine, Bulk stock, & Packaging area. This is the second layout consisting of 2 sides across a central corridor. The movement of materials from one area to another is the same as in the 1 st layout. 7

Advantage : :

Advantage : Owing to the modified layout, the flow is basically circular, eliminating much of the crossover traffic present in the 1 st layout. Disadvantage : Though much of the crossover traffic is eliminated, chances of contamination are still significant enough. 8

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It consists of a basic straight line flow to minimize contamination or mix-up, moving the materials along a critical path. Advantage : The principal advantage over the layouts is minimal cross-over of materials , thus minimizing the potential for contamination or mix-up. Disadvantage : One disadvantage is the additional space required to accommodate this configuration. 10

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(B) Control of cross contamination ::

(B) Control of cross contamination : Air handling systems : It is one of the most important considerations in the design of a solid dosage form. The C-GMP regulation 211.46 section c specifically mandates that : “ Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.” 12

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Dust collection : Sampling and weighing 13

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The first area that must be addressed is the raw material sampling rooms and the pharmacy or dispensing area. The area should be an enclosed facility with separate booths or hoods where the individual weighing or sampling can take place. These areas may be designed using horizontal laminar flow or appropriate hoods and other dust pick up devices. The supply air to these stations will, therefore, either be HEPA filtered at the pick up stations or HEPA filtered after the dust collection prior to returning to the general area or supply air. 14

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Granulating : There are 2 basic methods of air system design. In the following illustration, the mixing rooms are negative to the main corridor. This prevents air borne particles from escaping into the main area and migrating to the other rooms. 15

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Compression : The following figures illustrate a tablet compression room design using slightly negative pressure in the corridors to preclude contamination of other booths through open doorways. Both methods, designed and maintained properly, will work equally as well. The important point being the supply air is pre-filtered through a dust collector and final filtered through a HEPA filter. 17

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Packaging : Some tablet-filling machines are designed with a self-contained vacuum system that returns the air, filtered through an absolute filter, back to the packaging area. If the filling machine being used does not have an air filtering system, dust pick-ups of approximately 300 CFM should be provided at the hopper station and 50 CFM at the bottle chute. 20

(C) Humidity/temperature controls ::

(C) Humidity/temperature controls : From the standpoint of both product protection and employee comfort, careful consideration must be given to humidity and/or temperature controls. Unless otherwise indicated, conditions of 45% R.H. and 70⁰ F are generally adequate for critical manufacturing areas such as compression and coating. The ventilation could be provided by large roof fans to circulate air. In addition, some form of supplemental air heating, such as hot-air blowers, should be provided for cold areas, such as shipping or receiving docks. 21

(D) Water systems : :

(D) Water systems : CGMP regulation 211.48 states : “that the supply of potable water in a plumbing system must be free of defects that could contribute contamination to any drug product.” The USP XXI defines purified water, USP, as water obtained by process such as ion-exchange treatment, reverse osmosis, distillation, electro dialysis and ultra filtration or other suitable processes. Classes of water normally encountered are : 1.Well water, 2.Potable water, USP. 3.Purified water , USP. 4.Specially purified grades of water, such as water for injection, USP, or 5. FDA water for cleaning and initial rinse in parenteral areas. 22

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1. Well water : It is the water drawn directly from a well. The water may not be either chemically or microbiologically pure because it is untreated. 2. Potable water : It is city water or private well water that has usually been subjected to some form of microbiological treatment, such as chlorination, to meet the US public health services standard with respect to microbiological purity. 3. Purified water : It is usually prepared from water that meets the potable water standard. Purified water is treated to attain specified levels of chemical purity and it is the type of water used in most p’ceutical processing operations. 23

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Water treatment equipment : De-ionization equipment should be sized to ensure frequent regeneration and a re-circulating system should be installed on the unit that approaches the rated flow of the de-ionization unit. Water filtration : It is approached on the basis of 2 major considerations : Prefiltering : To prevent large particulates from entering the system. The prefilters are generally the replaceable cartridge type with porosities ranging as high as 25 µ . Micro filtering : To remove bacteria . Micro filtering is usually accomplished with a 0.2 µ absolute filters, which will remove most bacteria. 24

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Sanitization procedures : It is best accomplished through several methods. After periods of low usage of water, the system should be flushed with a supply of water that has residual chlorine. Periodic hyper chlorination also is recommended. Effective microbial control can be maintained by storing water at 80⁰c. U.V. radiation may be used, but it has limited application because of the many factors which can reduce it’s effectiveness. 25

(E) Plant pest control ::

(E) Plant pest control : The CGMP regulation 211.56(a) states that : “Any building used in the manufacture, processing, packing or holding of a drug product shall be maintained in a clean and sanitary condition. Any such building shall be free of infestation by rodents, birds, insects and other vermin. Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.” A pest control program should be developed that will ensure the integrity and quality of products produced and comply with existing legislation. The program should contain a list of approved pesticides to be used in the plant. Individual sheets should be prepared for each specific item of use. 26

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Basic information should be spelled as follows : Classification. Type of action. Chemical name and concentration of active ingredient. Effective for : To be used for : Area of usage. Trade name of the pesticide. Mode and frequency of application. Toxicities and any specific toxic symptoms, if known. Status of government approval. Specific restrictions and cautions. 27

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The development of sheets will serve a 2 twofold purposes : The sheets can be subjected to approval by the plant safety organization to determine if the materials comply with the Occupational safety and Health administration (OSHA) requirements and the requirements of other state or local agencies. The sheets would also facilitate compliance with the CGMP regulation 211.56 (c). Written records of regularly scheduled inspections and preventive treatments should be maintained. Emergency or special services should be documented specifying : The type of problem encountered, The service rendered, Effectiveness of the treatment, & Any follow up that might be required. 28

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The program should also specify when production interruptions might be necessary , either due to the presence of a specific pest or to avoid possible contamination during the treatment to exterminate a pest. All manufacturing areas should be constructed using non porous materials on the walls of the floors. Any protrusions such as pipes and electrical walls should be minimized . Spacing should be allocated carefully to provide sufficient rooms for all operations. There should be adequate lightning and the areas should be remote from any openings to the outside . Care should be taken that adequate training in understanding CGMPs be given to all personnel. Outside contractors must also be trained and understand CGMPs before embarking any construction or remodeling efforts having to do pharmaceutical manufacturing. 29

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