Equipments

EQUIPMENTS, Equipment may be defined as a physical entity which is used to carry out a general or specific activity in the plant.

1. M . PHARM, 2 nd SEMESTER EQUIPMENTS

2. What is an equipments..??? Equipment may be defined as a physical entity which is used to carry out a general or specific activity in the plant.

3. Types of Equipments Single piece E.g - tablet compression m/c, a mixer, HPLC, FTIR, weighing balance etc. Integrated system E.g - water demineralising plants, an air handling system etc.

4. Management of Equipments in Pharmaceutical Plants as per International GMP Literature Location Design Construction Size Adaptation Cleaning & cross-contamination Preventive & Breakdown maintenance

5. Contd …… Installation,calibration , qualification, validation Automatic, mechanical, electronic equipment, including computers Filters Weighing balance

6. Life cycle of an Equipment Decision to purchase an Equipment Purchase of the Equipment Qualifying, installation validating the Equipment Using the Equipment (operation, cleaning and maintenance) Preventive maintenance and revalidation Replacing the Equipment

7. Contd …… Why, how, level of technology, send to suppliers the factory acceptance test is done Expected life, capacity prepared as at fabricators premises equipment is received SOPs are made qualification validation SOP how to operate process like IQ,DQ PQ For maintenance are made replaced by new better advanced equipment

8. WHO Guidelines for Equipments Equipments must be located, designed, adapted and maintained to suit the operation to be carried out. Equipments should be installed in such a way as to minimize any risk of error or of contamination . Production equipment should be designed , located, and maintained to serve its intended purpose. Production equipment should be designed, so that it can be easily and thoroughly cleaned on schedule basis. Production equipments should not present any hazard to the products.

9. Equipment Identification WHO Guidelines: Fixed pipe work should be clearly labeled to indicate the contents and, where acceptable, the direction of flow. All service piping and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases and liquids.

10. Equipment Cleaning & Maintenance WHO Guidelines The layout and design of the equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance. Washing and cleaning equipment should be chosen and used so as not to be source of contamination. Defective equipment should, if possible, be removed from production and Q.C. or at least clearly labeled as defective.

11. Filters As a part of GMP, filters should be considered from the following points- Types of filter and filtration process Compatibility of filter media with processing materials Cleaning of reusable filters and their sanitation Validation of filters Disposal of filter s

12. Weighing Balance WHO Guidelines Balances and other measuring equipment of an appropriate range and precision should be available for production and control operation and should be calibrated on a scheduled basis.

13. Weighing balance should be made with following details Description of balance Model no. Manufacturer name Weighing range Least count Frequency of calibration Location of balance

14. Documents and formats to be maintained for every equipment Name and unique identification number of the equipment Equipment manufacturers, name and address. Additional information on contact persons and their mobile phone numbers may be useful Equipments capacity in terms of holding and output

15. Contd …. Materials of construction of drug contact parts Electric power requirement details Utilities required to operate the equipment e.g.- water, steam, compressed air etc

16. Indian Pharmaceuticals Ltd. Machine Breakdown Card Sr. no. Date Time Type of Breakdown Maintained work performed Time In house/Ext sign Part name/part No. Replaced required From To Att. By Checked by 16 Name of machine: Department:

17. Indian Pharmaceuticals Ltd. Machine History Card Sr.No . Date Time Nature of problem Modification made/rectification made Time Sign           From To Atte Checked by                                                                                                             17

18. Indian Pharmaceuticals Ltd. List of Equipment Sr. No. Name of equipment Capacity holding/output Make Date of installation Materials construction of contact part made up of 18

19. Indian Pharmaceuticals Ltd. Die Punch Inspection Report Sr. No. Tip size Body diameter Head Overall length Working length Cup depth Reading 1 Reading 2 Go No go 19

20. Indian Pharmaceuticals Ltd. Equipment/ Instrument Services History Card Sr. No. Details of repairs servicing/calibration Service called on Equipment attended on Serviced by Remark 20

21. Indian Pharmaceuticals Ltd. Equipment Details Card Drive Details  ------------------------------------------------------------------------------------------- Gear Box ------------------------------------------------------------------------------------------ Vacuum Pump ----------------------------------------------------------------------------------------- Air Compression …………………………………………………………………………….. Vibrator ------------------------------------------------------------------------------------------------ Coupling ---------------------------------------------------------------------------------------------- Chain and Sprockets ------------------------------------------------------------------------------------------------ Pully and V Belt ------------------------------------------------------------------------------------------------- Bearing Details ------------------------------------------------------------------------------------------------ Fasteners ------------------------------------------------------------------------------------------------------------ 21

22. REFERENCES Potdar A. M., “CURRENT GOOD MANUFACTURING PRACTICES for Pharmaceuticals”, Equipment (Chapter 3), PharmaMed Press, Hyderabad, 1 st Edition, 2008, pp- 85-100 Sharma P. P., “How to Practice GLP”, Practice of GLP (Equipment) Chapter 7, Vandana Publications Pvt. Ltd., Delhi, 2 nd Edition, 2008, pp- 245-261 Shah H.D., “QA MANUAL”, Equipment (Chapter 5), Business Horizons, New Delhi, 1 st Edition (2 nd Reprint), 2007, pp- 68-89 Sharma P. P., “How to Practice GMPs”, Practice of GMPs (Equipment) Chapter 3, Vandana Publications Pvt. Ltd., Delhi, 4 th Edition, 2004, pp- 187-193