pharmaceutical packaging containers

Quality control ,standard and testing of pharmaceutical packaging: 

Quality control ,standard and testing of pharmaceutical packaging By- Arti Kesarwani M.Pharm ( P’Ceutics ) Invertis University

Packaging : 

P ackaging Packaging is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use .

Importance of packaging: 

Importance of packaging • Protect against all adverse external influences that can alter the properties of the product. • Protect against biological contamination . • Protect against physical damage . • Carry the correct information and identification of the product . • Tamper evident / Child resistance

Quality control: 

Quality control Quality is the backbone of any p’ceutical industry, regardless of whether it concerns with the quality of medicines or packaging material. To ensure high quality of p’ceutical packs ,the quality management system must take into consideration the necessities of the local authorities and the legislation ,the raw material, the product, the production process and the policy of the manufacturer. The defects in packaging may have harmful affect on the dosage form.

Contd….: 

Contd …. The QC test specification must be built around the component specification and should be designed to achieve consistency through identifying the product ,market and the production requirements. The QC testing programme depends upon the company policy ,type of material ,the market use ,etc.

Laboratory analysis: 

Laboratory analysis The laboratory routine analysis should include- Visual inspection Identification test Dimensional test Physical tests Chemical tests Microbiological tests Performance measurements

Designing: 

Designing The foremost requirement for packaging must be a good design as relevant to the need of the product, product-pack stability, compatibility, manufacturing and distribution system, the patient, and the legislation. Product/component stability parameters to b studied include moisture and gas protection,light and temperature protection, microbiological integrity ,pH stability, preservatives, stabilizers, plasticizers etc.

Basic requirements for commonly used dosage forms: 

Basic requirements for commonly used dosage forms The information regarding the product, storage, condition,administration and use etc. should be mentioned in labelling . Such as- Name of product Quantity Content Batch no. Mfg.date Exp.date Direction for use Storage conditions Name and address of manufacturer

Tablets : 

Tablets The following are the labelling requirements for tablets- Store in well closed containers protection from light ,moisture, crushing and mechanical shock. Special tablets e.g. effervescent tb should stored in tightly closed containers /moisture-proof packs Effervescent tb should be labeled, “Not to be swallowed”

Capsules : 

Capsules Labelling requirements are- Store/pack in a manner that protects them from microbial contamination. Keep in well closed containers. Protect from light ,excessive moisture ,or dryness. Do not store above 30 C

Topical semi-solid forms: 

Topical semi-solid forms Containers for these preparations should be made of material which does not affect the quality of the preparations. Container material does not allow diffusion of any kind into or across the container Closures for such preparations should be designed to minimize microbial contamination, Container should protect the preparation from light , moisture ,damage during handling and transportation.

Aerosols : 

Aerosols Avoid inhaling pressure. Do not expose to heat. Store at temp. not above 12˚ C. Do not inhale directly ; deliberate inhalation of contents can cause death. Use only as directed.

Packaging of blood and related products: 

Packaging of blood and related products Some of salient points mentioned in the USP XXVII are listed below: Plastics containers for the collection ,storage ,processing ,and administration of blood and its components should be sterile. The containers should be shaped in such a manner that when filled they may be centrifuged. It should not show any leakage. Vapor permeability should be very less. It should be resistant to temp. variations. It should comply with sterility tests and pyrogen tests, etc.

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TESTING OF CONTAINERS

TESTING OF CONTAINERS: 

TESTING OF CONTAINERS USP has prescribed various tests on the units as well as multiple dose containers such as – Hydrolytic resistance test Permeation test Light transmission test. Thermal shock resistance test. Collapsibility Test Test for clarity of aqueous extract,etc .

Testing of glass containers: 

Testing of glass containers Generally hydrolytic resistance and chemical resistance are carried out on glass containers. According to USP XXVII following are the tests- Powdered glass test Water attack test Hydrolytic resistance Arsenic resistance

Powdered glass test: 

Powdered glass test Transfer 10g of prepared specimen in a 250ml conical flask digested previously with purity water in a bath at 90˚C. Add to conical flask containing 50ml of high purity water. Cap all the flask. Autoclave (continue heating for 10min) Close vent cock Adjust temp. to 121˚C Hold the temp. (121˚C for 30 min) Reduce the heat. Cool the flask in running water. Decant water Wash the residual powdered glass with purity water. Add 5 drops of methyl red sol.

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Contd … Titrate immediately with 0.02N sulphuric acid Record the volume of 0.02N sulphuric acid Vol. doesn’t exceed that indicated in table for the type of glass concerned.

Water attack at 121˚C: 

Water attack at 121˚C Rinse 3 or more containers twice with high purity water. Fill each container to 90%of its overflow capacity Cap all the flasks ,autoclave for 60 min Empty the contents and pool the contents in 250ml conical flask to a vol. of 100ml Add 5drops of methyl red sol. Titrate with 0.02N sulphuric acid while warm Record the vol. consumed Vol. doesn’t exceed the value as per USP

Types of glass and their test limits: 

Types of glass and their test limits Type of glass General description of glass Type of test Limit size, ml Limits (ml of 0.20N) I Highly resistant , borosilicate Powdered glass All 1.0 II Treated soda-lime glass Water attack 100 or less 0.7 Over 100 0.2 III Soda-lime glass Powdered glass All 8.5 IV General purpose soda-lime glass Powdered glass All 15.0

Plastic containers: 

Plastic containers Leakage test (Non- injectable & injectable )(IP 1996)

Water vapour permeability test for plastic containers for injectable prep.(IP 1996): 

Water vapour permeability test for plastic containers for injectable prep.(IP 1996)

Collapsibility test for plastic containers(Non-injectables & injectables)(IP 1996): 

Collapsibility test for plastic containers(Non- injectables & injectables )(IP 1996)

Fragmentation test for rubber closures : : 

Fragmentation test for rubber closures : Place a 4ml of water in each of 12 clean vials. Close a vial with closure and secure caps for 16 hrs. Pierce the closure with 21 SWG hypodermic needle. Repeat the operation 4 times for each closures ( use new needle for each closure). Count the number of fragment visible on the rubber . Total number of fragment should not be more than 10 except butyl rubber

FEATURES ENSURING QUALITY: 

FEATURES ENSURING QUALITY Protection A container intended to provide protection from light,or offered as a light resistant must meet the requirements of the USP Light transmission test. The ability of a container to protect against moisture can be identified be performing the USP Water Vapour permeation test. Compatibility Compatibility components will not interact with the dosage form & may not show leaching. Other changes such as pH shift ,precipitation , discoloration should be evaluated.

Safety : 

Safety Packaging components should be constructed of material that will not leach harmful or undesirable amounts of substances. Two extraction medium are used,purified water and isopropyl alcohol. The extraction is performed under specific temp. and time period.

References : 

References www.wikipedia.com/packaging www.authorstream.com www.slideshow.com Lachman and Lieberman, “Textbook of Industrial Pharmacy”,Volume -6 th ,Page no.705 Jain and Nayak , “Pharmaceutical Packaging Technology”, Volume- 2008, Page no.141-154

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THANK YOU…!!