Premiseskunal c mehta.Department of Quality Assurance : Premiseskunal c mehta.Department of Quality Assurance Content : Content Pharmaceutical industry
Design & Construction
Plan and layout
Sterile Areas Pharmaceutical industry : Pharmaceutical industry Pharmaceutical industry can be classified arbitrarily on the following :
Crude and processed botanical drugs
Fine chemical and pharmaceuticals
Proprietary drugs Location : Location The selection of a location for the construction of a pharmaceutical or chemical plant is a vital decision to be taken, because it determines the balancing of investment and profit.
The factory building (s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environment including open sewage, drain, public lavatory or any factory which produces disagreeable or obnoxious, odour, fumes, excessive soot, dust, smoke, chemical or biological emissions. Factors for location : Factors for location Fundamental (primary) factors
Derived (secondary) factors Fundamental (primary) Factors : Fundamental (primary) Factors Raw materials
Labour supply Derived (secondary) factors : Derived (secondary) factors Climate and soil
Flood and Fire Protection
Community Factors Design & Construction : Design & Construction The building(s), used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the conditions laid down in the Factories Act, 1948 (63 of 1948). Construction (contn…) : Construction (contn…) The premises used for manufacturing, processing, warehousing, packaging labeling and testing purposes shall be :-
compatible with other drug manufacturing operations
Proper Space for Working should be there.
Proper logically placement of equipment and material
Avoid the risk of mix-up between different categories of drugs or with raw materials, intermediates and in-process material. Contn…. : Contn…. 5. Control the cross contamination by other drugs or substances.
6. Deign should such that it prevent the entry insect and rodents.
Interior surface (walls, floors and ceilings) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection.
Provide with adequate lighting and ventilation, if necessary air conditioning to maintain a satisfactory temperature. Contn…. : Contn…. 9. The interior surfaces shall not shed particles.
10. A periodical record of cleaning and painting of the premises shall be maintained.
11. It should be proper underground drainage system in the processing area as far as possible.
12. Sanitary fitting and electrical should be concealed. Contn… : Contn… Water supply: The water used in manufacture shall be pure and drinkable quality, free from Pathogenic microorganism.
Disposal of waste: Waste water and other residues from laboratory which might be prejudicial to worker or the public health shall be disposed of after suitable treatment as per requirement of water pollution control authorities. Plan and layout : Plan layout is a coordinated effort to achieve the final objective to integrate machines, material and personal for economic production. Plan and layout Advantages of plan layout : Advantages of plan layout A proper lay out has the advantages from point of
Other production cost
Capital investment. Type of plan layout : Type of plan layout Plant layouts are of two types:
Process layout or functional layout
Product or straight line layout Process layout or Functional layout : Process layout or Functional layout DEFINATION : It the arrangement of machines of a particular class doing a particular type of work or process as a separate department.
Eg. All cutting machines may be placed in one department. i.e cutting department. Process layout (contn….) : Process layout (contn….) Advantages of process layout :
More effective supervision can be achieved
Division of Labour can be provided
Less disruption occur in production
High scope for expansion
This is not possible in chemical &Pharmaceutical industry Product or straight line layout : Product or straight line layout DEFINATION: The arrangement of machines doing various operation in a line as one department.
Eg. In manufacture of tablet; Dispensing, powder blending, granulation, drying , compression and coating.
All of the above look as different operation but logically arranged in a series. Product layout (contn….) : Product layout (contn….) Advantages:
Process of work will be quick and smooth
Cost of material handling will reduced
Production time is reduce and manufacturing cycle can be speeded up.
Space of floor can be properly used Factor Influencing Plant layout : Factor Influencing Plant layout New site development or additional to developed site.
Type of Process and product control.
Space available and space required.
Economic distribution of utilities and services.
Health and safety considerations.
Waste disposal problem.
Possible future Expansion. Method of Plant and Factory Layout : Method of Plant and Factory Layout A proper layout in each case includes arrangement of processing areas, storage area and handling area in efficient co-ordination
The lay out processing units in a plant, the equipment within these units must be planed.
Then detail piping, structural and electrical design.
Plan layout play important in determining construction and manufacture cost. Method of Plant and Factory Layout : Method of Plant and Factory Layout Method of Plant and Factory Layout : Method of Plant and Factory Layout Method of Plant and Factory Layout : Method of Plant and Factory Layout Different type of information are needed design an appropriate layout
Dimensions of work places.
Sequence of operations.
Flow pattern of materials.
Storage space for raw materials, in process inventory and finished goods.
Space for offices, aisles, toilets etc Special Provision of Pharmaceutical plant layout. : Special Provision of Pharmaceutical plant layout. They shall conform to the condition laid down in Factories Act 1948
The wall of room in which manufacturing operation are carried out shall:
Have a height of six feet from floor.
Have smooth and waterproof.
Be capable of cleaning. Slide 26: Flooring shall :
Be smooth, even washable.
Have no creak and crevices
Be in such a way as not to permit any retation or accumulation of dust. Different Type of Layout : Different Type of Layout Raw Material Ware House : Raw Material Ware House Center storage and Perimeter Production : Center storage and Perimeter Production Storage And Production Side by Side : Storage And Production Side by Side Straight Line Type : Straight Line Type Office layout : Office layout Warehouse layout : Warehouse layout Maintenance : Maintenance Many problem involved in maintenance due to the faculty design and layout of plant and equipment.
Sufficient space and facilities for maintenance work must be provided in plant layout.
It is essential to consider maintenance regulations while making decisions on equipment. Maintenance (contn….) : Maintenance (contn….) Schedule and procedures must be established for the preventive maintenance of equipment.
Written procedures must be established for the cleaning and its subsequent release for use in manufacturing.
Equipments and utensils must be cleaned, stored and wherever appropriate sanitized or sterilized to prevent contamination or carry over. Maintenance (contn….) : Maintenance (contn….) Non dedicated equipment must be cleaned between productions of different materials to prevent cross contamination. Sanitation : Sanitation It consist of three thing:
Disposal of sewage and refuse Sanitation : Sanitation Manufacturing area should not be used for any other purpose.
It should be maintain clean, orderly manner and free from accumulated waste, dust, debris etc.
Eating, chewing smoking or any unhygienic particle should not permitted in manufacturing area.
Production areas shall be well lit, particularly where visual on-line controls are carried out. Contn… : Contn… A routine sanitation program shall be drawn up and observed, which shall be properly recorded and which shall indicate--
(a) specific areas to be cleaned and cleaning intervals;
(b) cleaning procedure to be followed, including equipment and materials to be used for cleaning; and
(c) personnel assigned to and responsible for the cleaning operation. Environment control : Environment control Thermal pollution and control
Water pollution and control
Air pollution control Thermal pollution and control : Thermal pollution and control Various off stream cooling system are required to handle thermal discharge from process.
There different ways for controlling thermal pollution
Wet cooling towers
Dry cooling towers Water pollution : Water pollution There is a great problem to handling a liquid waste effluent is more complex then gas effluent.
The treatment could be done by
Biological treatment Air control : Air control There are two major categories
Those suitable for removing particulate matter
Those associated with removing gaseous pollutant
Removed by chemical And Physical way Sterile Area : Sterile Area For Sterile drugs separate enclosed area specially designed for the purpose shall be provided.
Area shall be provided with air locks for entry and shall be essentially dust free and ventilate with air supply.
For all areas where aseptic manufacture has to be carried out air supply shall be filtered through HEPA filters and shall be at a pressure higher than in the adjacent area. Sterile Area (contn….) : Sterile Area (contn….) Routine microbial counts of all sterile area shall be carried out during manufacturing operation.
Area where Manufacturing progress is going on that area must not be occupied by access people.
Special procedure should be followed for entering and leaving the manufacturing area References : References Theory And Practice Of Industrial Pharmacy By Leon Lachman, H.A. Liberman, Verghese Publication House, 3rd Edition, Dader, Bombay.
Laboratory Manual By Pamposh Kumar; V.P.S. Tomer; CBS Publishers and Distributors, Ist edition, 2005.
Documentation Basics That Support GMP By Carol Desain, Advanstar Communications, 1993.
Good Manufacturing Practices For Pharmaceuticals, A Plan for Total Quality Control, 3rd edition, west publishing company. Reference : Reference Pharmaceutical Engineering by C.V.Subrahmanyum, Vallabh Prakashan 3rd edition .
Pharmaceutical Production And Management by C.V.Subrahmanyum, Vallabh Prakashan, 3rd Edition.
Pharmaceutical Jurisprudence Dr G.K. Jani Atul Prakashan 7th Edition2008. Slide 48: Thank you