Principal Areas of a Pharmaceutical Manufacturing Facility

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It is a very peculiar decision when it comes to design a pharmaceutical facility. The first and foremost step is to generate User Specific Requirements (URS) which is decided according to what kind of pharmaceutical product is to be manufactured, the scale of generation (small scale or big scale facility). Various regulatory guidelines have been introduced that specifies the common areas for a pharmaceutical facility which are generally as follows:

A) Warehousing Area

B) Production Area

C) Quality Control Area

D) Ancillary Area

WAREHOUSING AREA:

Warehouse area

One of the crucial areas of a facility which is responsible for the storage of raw materials, packaging materials, intermediates, bulk and finished products, products in quarantine, released, returned, rejected an recalled products. There are some requirements that are specified in regularities when it comes to warehousing areas which are following:

  1. All storage areas should have sufficient capacity depending upon the product type to be stored. This is generally calculated in terms of pallate space which is one cubic meter for one pallate.
  2. The environmental conditions should be considered according to the type of product being stored which includes temperature, humidity and ventilation. Checks should be recorded and verified through the documentation.
  3.   Areas which are designed for the intake or dispatch should be such that they are not affected by the weather conditions while loading and unloading of materials, properly cleaned prior subjection to quarantine and should be physically partitioned from the main core area.
  4. Warehousing of the raw materials should be divided into different sections which include separate areas for active and inactive materials. Sampling of the raw materials should be such that they are conducted in their respective sections. Also liquids, solvents, inflammable, poisons must be stored according to the specified guidelines.
  5. The returned, rejected and recalled products should be kept in lock and key and necessary documentation and protection should be taken to avoid the mix ups.
  6. Printed and packaging materials are crucial so they must be secured safely in designated area.

PRODUCTION AREA:

Production Area

The main area of the pharmaceutical facility which is responsible for manufacturing of the pharmaceutical products. Some common points to be considered are:

  1. The products of different categories ( such as antibiotics, beta-lactum, steroids etc.) should be manufactured in different area which eliminates the risk of the cross contamination.
  2. The premises should be designed in such a way in production area that the flow of the material is justified.
  3. The area specified for the production should be hard, smooth, impervious which allows to handle the dangerous materials and also makes the cleaning and sanitization easy.
  4. Adequate light fittings, pipe work, ventilation and other services should be provided in the production area.
  5. Drainage system of production area should be of adequate size, sufficient in number and suitably located to prevent the backflow.
  6. Ventilation of the rooms should be proper by using HVAC systems and depending upon the type of pharmaceutical product being manufactured.
  7. Manufacturing area such as filling, punching of tablets should be segregated from the packaging lines to avoid the cross contamination.
  8. Also in production area the primary packaging area should be different from the secondary packaging areas to avoid mix ups.
  9. The light should be proper in production areas specially in the region where the visual checks are performed. For example: checking of ampoules for particles against the white or black background.

QUALITY CONTROL AREA:

Quality Control Area

These areas are dedicated towards testing of the bulk, intermediates and finished products. Areas where biological, microbiological or radio isotopes test methods are conducted, should be separate from each other. There are some laboratories that are designed in such a way that separate compartments are provided for Wet Chemical Analysis, Instrumental Analysis, Storage for glasswares, chemicals, control samples and documentation.

HVAC systems of high quality should be installed to prevent the cross contamination as weighing of samples is conducted during the conduction of test methods.

Separate room or area should be designated to highly sensitive instruments such as HPLC, Gas Chromatograph, Infra Red Spectroscope etc. to protect them from electical interference, vibration, contact with excessive moisture and other external factors.

ANCILLARY AREAS: 

These areas are of equal importance when a facility is designed. These areas cover:

  1. Rest and refreshment rooms
  2. Toilets and wash areas
  3. Clothes storage areas
  4. Change room for employees
  5. Engineering Workshops
  6. Animal House and similar areas
  • It should be taken care of that toilets should not communicate directly with production or storage areas.
  • The change rooms must be such that they are easily accessible to all the employees and there should be allotment of specific cabinets to individual employee.
  • Areas for washing and toilets should be adequate in number and easily accessible.
  • Separate engineering departments should be made and if not possible than the tools and parts should be stored in lock and key in production areas.
  • If any kind of animal house is present then it should be isolated from other areas and must have separate entrance,

 

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