Packaging validation

Validation of Packaging operations

1. A SEMINAR ON VALIDATION OF PACKAGING OPERATIONS Presented by: Guided by: MR. GOMTESH MILIND DOSHI Dr. S.S CHITLANGE M. Pharm.1 st year[QAT] Sem -II Principal & Professor Roll No. 526 Dr. D Y Patil IPSR,PIMPRI,PUNE 1 Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pimpri , Pune

2. Content Introduction Of Packaging Characteristics Of Packaging material Role Of Packaging Key Areas That Affects Packaging Process Validation Of Packaging Packaging Equipment Qualification Packaging Process Validation Example Of Packaging Process Blister Packaging For Tablet Secondary Packaging Checkweigher Bibliography 2

3. Packaging Pharmaceutical packaging has to be carried out for the purpose of the safety of the pharmaceutical preparations in order to keep them free from contamination, hinder microbial growth, and ensure product safety through the intended shelf life for the pharmaceuticals. Packaging : may be defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. 3

4. Characteristics Of Packaging Materials: Must be FDA approved Must be non toxic Must not impart odor/taste to the product Must not reactive with the product They must protect the preparation from environmental conditions 4

5. Role of Packaging Protection Against physical damage Against biological contaminations From all external influences that can alter the properties of product Identification of product Convenience in use for medical staff and patient A marketing tool 5

6. several key areas that affect packaging process Packaging Material Packaging Equipment Packaging Line Layout Training Of Operators 6

7. Types Of Packaging Material Primary packaging material: material which directly comes in contact with medicinal product E.g.: Ampoules , Vials , Containers , Syringe , Strip package, Blister packaging. 7

8. Secondary packaging material: material which comes in contact with primary packaging material E.g. Paper and card board boxes 8

9. Printed Packaging materials : All packaging material which have anything printed on it E.g. labels, medicinal literatures 9

10. Tertiary packaging material : used for bulk handling , warehouse storage and transport shipping E.g. carton boxes 10

11. Packaging Equipment Packaging equipment carries higher contribution towards the packaging quality of pharmaceutical product. In case of older equipment, they have greater the number of stages and lower efficiency. In modern technology packaging equipment enhances the productability as well as quality. 11

12. Packaging Line Layout 12

13. Product feeder Packaging material Weigh check Carton closer Check Device Product in carton (feeder) Labeling operation Device (Product counter) Filling operation Sealing operation Leaflet inserter Check Device Weigh Check Device Check Device Check Device Label Check Device Seal Check Device 13

14. Packaging Line Layout Layout of packaging line should be:- Easy to access for operators, operational engineers, and validation personnel Perform line clearance between batches of product as well as different products Cleaning of the line is must be easy and controllable manner. Ability to manage quick change over. 14

15. Training Of Operators Training of operators and engineers on packaging line is integral part of equipment installation and qualification. Supplier should identified training needs and provide appropriate training. It is important to periodically review training requirements Record of training and experience should be maintained. 15

16. Validation Packaging validation is establishing documented evidence, which provide high degree of assurance that a specific packaging process performed, will consistently produce a pack, which meets predetermined specification. Validation must be performed by person with the necessary education, background, training, experience and qualification. Validation program must be documented and approved. 16

17. Packaging Validation 17

18. Packaging Equipment Qualification User requirement specification:- Prepare prior to purchase of equipment Specification includes Purpose of equipment Target production rate Size & location of equipment Safety consideration Types of maintenance required 18

19. Design Qualification:- DQ protocols is for conformance of the system to URS and GMP requirements Installation Qualification:- IQ protocol is checklist to ensure that the system or equipment is properly is properly installed. In this engineering drawing should be checked and updated as appropriate. 19

20. Operational Qualification:- OQ protocol will challenge to system to demonstrate that it can operate within specified parameters. Challenge the upper and lower operating limits, to test the process and system. Performance Qualification:- PQ should performed in normal daily operation Testing of each piece of equipment Test interaction between different pieces of equipment Test all critical steps. 20

21. Packaging Process Validation Packaging process validation is performed when new product is being packed for the first time on existing packaging line, using current or new packaging material. Packaging process validation should start with preparation of protocol called Validation protocol. 21

22. Validation Protocol : Short description of the process with a summary of the critical processing steps or critical parameters to be monitored during validation. Additional testing intended to be carried out e.g. with proposed acceptance criteria and analytical validation as appropriate. Sampling plan:- where, when , how and how many samples are taken. Details for recording and evaluation of results. 22

23. Tests Performed By Medical Lab Toluidine blue test :- for detecting seal leaks in porous medical packaging by dye penetration Visual inspection test :- for determining integrity of seals packaging by visual inspection e.g. of defects: unsealed areas, non homogeneous area Immersion test:- sample is placed in a container filled with water for 20 sec., it is verified that no air bubbles escape from the sealing or the packaging. Accelerated aging :- packaging samples are placed in the thermo-regulated chamber at 55°C for accelerated aging. During the whole aging time, temperature of the chamber is monitored. After aging, the packaging are tested. 23

24. BLISTER PACKAGING FOR TABLET 24

25. Printing labeling details on Alluminium foil Alluminium foil Delivery 25

26. Blister Packaging Operation 26

27. Critical parameters or Steps Optimization of temperature Packaging machine speed optimization Verification of film forming and sealing temperature Verification of packaging machine speed Efficiency of tablet feeder Blister formation inspection system efficiency Printing efficiency Blister cutting efficiency Blister counting efficiency 27

28. Secondary Packaging 28

29. Carton Delivery Leaflet Insert Delivery Visual checking system Visual checking system 29

30. Checkweigher 30

31. Checkweigher 31

32. Bibliography Chitlange S. S., Chaudhari P. V., Shirsat A.K., and Sangshetti J. N., “Pharmaceutical Validation”, Suyog Publication, 1 st edition ,2014, Page no. 9.1-9.11. M.A. Potdar “Pharmaceutical quality assurance”, Nirali publication, 4 rd edition, 2015, Page no.8.31-8.38 Agallow J., Frederick J., “Validation of pharmaceutical processes” CRC Press, 3 rd edition, Page no.429-442 32

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