Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment 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.
- Equipment should be installed in such a way as to minimize any risk of error or of contamination.
- Fixed pipework should be clearly labeled to indicate the contents and where applicable, the direction of flow.
- All service piping’s and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases and liquids.
- Balances and other measuring equipment of an appropriate range and precision should be available for production and control operations and should be calibrated on a scheduled basis.
- Production equipment should be thoroughly cleaned on a scheduled basis.
- Laboratory equipment and instruments should be suited to the testing procedures undertaken.
- Washing, cleaning and drying equipment should be chosen and used so as not to be a source of contamination.
- Production equipment should not present any hazard to the products. The parts of the production equipment that come into contact with the product must not be reactive, additive, or absorptive to an extent that would affect the quality of the product.
- Defective equipment should be removed from production and quality control areas. If this is not possible, it should be clearly labeled as defective to prevent use.
- Closed equipment should be used whenever appropriate. Where open equipment is used or equipment is opened, precautions should be taken to minimize contamination.
- Non-dedicated equipment should be cleaned according to validated cleaning procedures between productions of different pharmaceutical products to prevent cross-contamination.
Direct Compression, Wet Granulation and Dry Granulation. It will continue with a detailed review of all the major unit operations associated with OSD manufacturing processes. This includes: Ingredient Dispensing / Formulation; Blending; Granulation; Drying; Compression / Encapsulation; Coating; Packaging and Miscellaneous Operations.
TABLETS:
The Tablet section shall be free from dust and floating particles and may be air-conditioned. For this purpose, each Tablet machine shall be isolated into cubicles and connected to a vacuum dust collector or an exhaust system. For effective operations, the Tablet production department shall be divided into distinct and separate sections as follows: –
(a) Mixing, Granulation and Drying section.
(b) Tablet compression section.
(c) Coating section (wherever required).
The following electrically operated equipment are recommended for the manufacture of compressed Tablets, in each of the above sections;
(a) Granulation-cum-Drying section:
(1) Sifter
(2) Powder mixer
(3) Mass mixer/Planetary mixer/Rapid mixer granulator.
(4) Granulator
(5) Thermostatically controlled hot air oven with trays (preferably mounted on a trolley) / Fluid bed dryer.
(6) Milling / Screening Machine
(7) Weighing machines.
(b) Compression section:
(1) Tablet compression machine, single/multi punch/rotatory.
(2) Punch and dies storage cabinets.
(3) Tablet de-duster
(4) Metal Detector
(5) Tablet Inspection unit/belt.
(6) Dissolution test apparatus
(7) In-process testing equipment like single pan electronic balance, hardness
tester, friability and disintegration test apparatus.
(8) Air-conditioning and dehumidification arrangement (wherever necessary)
(c) Coating section:
(1) Jacketed kettle (steam, gas or electrically heated for preparing coating suspension).
(2) Coating pan (stainless steel)
(3) Polishing pan (where applicable)
(4) Exhaust system (including vacuum dust collector)
(5) Air-conditioning and dehumidification arrangement.
(6) Weighing balance.
The Coating section shall be made dust free with suitable exhaust system to remove excess powder and fumes resulting from solvent evaporation. It shall be air conditioned and dehumidified wherever considered necessary.
CAPSULES:
For the manufacture of Capsules, separate enclosed area suitably air-conditioned and dehumidified with an airlock arrangement shall be provided. The following equipment is recommended for filling Hard Gelatin Capsules, namely:
(1) Mixing and blending equipment (electrically or power driven).
(2) Empty Capsule Elevator
(3) Capsules filling units (preferably semi-automatic or automatic filling machines).
(4) Metal Detector
(5) Dedusting and Polishing Machine (For Powder filled capsules)
(6) Mini Capsule Sorter
(7) Empty Capsule Sorter
(8) Capsules checkweigher/counters (wherever applicable)
(9) Weighing balance.
(10) Disintegration test apparatus.
PACKAGING:
When the programme for packaging operations is being set up, particular attention should be given to minimizing the risk of cross-contamination, mix-ups or substitutions. Different products should not be packaged in close proximity unless there is physical segregation or an alternative system that will provide equal assurance.
(1) Strip / blister packaging machine.
(2) Leak test apparatus (vacuum system)
(3) Auto-Cartonating Machine
(4) Check weigher
(5) Security seal labeling machine
(6) Shrink wrapping machine
(7) Bulk Packing machine – Tablet counters
(8) Metal detector
(9) Desiccant / Cotton Inserter Machine
(10) Capping Machine
(11) Induction sealing Machine
(12) Re-torquer Machine
(13) Labeling Machine
(14) Outsert (PIL) inserter Machine
(15) Track and Trace (Serialization unit)
(16) Shipper Packing