sterilization of pharmaceutical packaging

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STERILIZATION OF PHARMACEUTICAL PACKAGING MATERIAL Submitted By VIVEK CHAUHAN Supervisor Co- Supervisors Prof. K. K. Jha Arun Kumar Director Sachin Kumar Department of Pharmacy NKBR College of Pharmacy and Research Centre 2009


INTRODUCTION Pharmaceutical packaging is the means of providing protection, presentation, Identification and information, containment and convenience to encourage compliance with a course of therapy.


TYPES OF PACKAGING Primary packaging materials are indirect contact with the product. This also applies to the closure which is also part of the primary pack. It is important that this container must not interact with the medicine from damage and from extraneous chemical and microbial contamination. In addition, the primary packaging should support use of the product by the patient. Secondary packaging's are additional packaging material that improve the appearance of the product and include outer wrappers on labels that do not make direct contact with the product. Secondary packages can also supply information about the product and its use. They should provide evidence of tampering with the medicine.

Material Used For Packaging:

Material Used For Packaging Glass Plastic Metal Paper and board




TYPES OF PLASTIC 1.Polyethylene (polythene) 2.Polypropylene 3.Polyvinyl Chloride (PVC) 4.Polymethyl methoacrylate (PMMA) 5.Polystyrene 6.Polytetra fluoroethylene (PTFE) 7.Polyamide (NYLON)


TYPES OF METALS Tin Aluminum Lead

Using paper-based material:

Using paper-based material Wrapping material Fiber drum. Certain composites—spiral and convolute wood containers Multiwall paper sacks, bags, and bales Lined carton system, bag in box, etc.


DEFECTS IN PACKAGING Class A- Critical defects Class B- Major Defects Class C- Minor defects


DEFECTS IN PHARMACEUTICAL CONTAINERS Lack of heat seal- incomplete heat seal Delimitation, channels voids and contaminations Inclusions of product or foreign materials in the seal area Misplaced lids/tops/closures or crimp seals Invisible defects/ leaks Holes or crack defects in empty vials/ ampoules


LITERATURE REVIEW Jacobs, GP”The literature on the effects of gamma -radiation on drugs, relevant to their sterilization or decontaminating, is reviewed. This literature survey essentially covers the past 7 yr, although relevant reports not covered in previous reviews have been included.” Kenneth C. “A guide for stabilization of pharmaceuticals to oxidation is presented. Literature is presented with an attempt to be a ready source for data and recommendations for formulators. Liquid and solid dosage forms are discussed with options including formulation changes, additives, and packaging documented. In particular, selection of and methods for use of antioxidants are discussed including recommended levels.”

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Boess C.“A survey was made of the relevant literature on experimental irradiation of alkaloids, morphine derivatives, and alkaloids; the results of 98 investigations of 67 different substances from 33 different sources were compiled and discussed. Twenty-one substances were investigated more often than once, 12 of them twice, 2 of them three times. The most data are available for morphine hydrochloride (six studies), atropine sulfate (seven studies), chloramphenicol (eight studies), streptomycin (five studies), and tetracycline (four studies). Irradiation was carried out in the dose range 5-750 kGy, in most cases between 10 and 60 kGy.” Wekhof A.“The report shows experimental data that Pulsed UV light was efficient to remove to 6 log of A. Niger, B. Pumilus and B. Subtilis 106 from a pharmaceutical (saline) solution packaged in a clear 100 micron plastic foil. Another new data demonstrated that PUV is equally effective in removing 6 logs of micro-organisms spread over a larger area ( within a circle of 5 cm) and the same amount of micro-organisms concentrated a small spot of 2 mm, by that fulfilling NFL requirements. We also have demonstrated that simple stainless steel surgical tools like scalpel can be sterilized wet after washing placed on quartz tray between 2 flash lamps. The report also has a brief summary of the method principles, published by our group earlier.”

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Thomas W “ Studied unmanaged packages that can be used for a one-time distribution, like a template. These are ideal for sharing application templates or code samples. For example, the package created in the tutorial was an unmanaged package.” Wheaton, I.L.“Studied the different type of plastics. Plastics are synthetic polymer of high molecular weight. Plastic is made from one or polymers together with certain additives. The polymers commonly used as polyethylene, polypropylene, polyvinyl chloride, polystyrene, polymethyl acryl ate.” Paul Hook Joe. Heimlich ” Studies that Sterilization is a term for several types of pre-formed plastic packaging material used for small consumer goods. Sterilization is an inexpensive option for creating packages that are durable, transparent, and tamper proof.1690”

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Keitch L. smith ” Studies that the primary consideration for the design of a packaging relies within the customer’s need for strength and consistency within the part. “ Jain U.K ”Studies that pharmaceutical packaging and technology of packs and packaging material. Package of growing improving importance and so a chapter is included on this topic .” Brody A.L . ” Studies the Wiley Encyclopedia of packaging technology and packing of tablet and capsules.1997 ” Wilmington, DE ” studied 3-D SMART™ Product Suite for Packaging 3-D Scanning and Drawing technology uniquely connects package design with production reality to establish a standard engineering design policy for pharmaceutical packaging Montesino Associates, LLC and Prodieco Pharmaceutical Components today released a suite of products based on their new 3-D SMART™ technology. 3-D SMART™ combines 3-dimensional scanning. 2004 ”

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Thomas son, W. A.” studied that packing dramatically improve medication compliance in elderly monthly pharmacist-provided education plus provision of all medications in time-specific packs dramatically improves medication compliance in elderly patients taking multiple medications, according to research presented here at the 2006 Scientific Sessions of the American Heart Association (AHA). Presented at AHA By CHICAGO, 2006”


STERILISATION OF PACKAGIMG MATERIAL The objective of sterilization process is to remove or destroy all micro-organisms in or on a preparation/material and to assure in this way the preparation is free of contagious hazards in all respect.




STEAM STERILIZATION (HEATING IN AN AUTOCLAVE) This process involve heating in an autoclave with saturated steam under pressure should be used whenever possible for aqueous preparations and for surgical materials. An aqueous product which are then sealed so as to exclude micro-organisms. It is then exposed to saturated steam for a time sufficient to ensure that the entire contents of each container are maintained for effective combinations of time and temperature to ensure sterility.


DRY HEAT STERILISATION This process is suitable for heat-stable, non-aqueous products and powders. A preparation to be sterilized by dry heat is distributed in the final containers which are then either finally sealed or temporarily closed to exclude micro-organisms and then heated so as to ensure that the entire contents of each container are maintained for an effective combination of time and temperature to provide an adequate assurance of sterility.


GAS STERILIZATION The method involves exposure to a sterilizing gas. The gas generally employed in gaseous sterilization is ethylene oxide of acceptable sterilizing quality. The process is difficult to control, the gas itself being toxic and, when mixed with certain proportions with air, explosive. Care should be taken to ensure that the process is applied only to packaging materials compatible with the sterilizing gas. The packaging material to be sterilized is exposed to ethylene oxide or to a mixture of ethylene oxide with a suitable inert gas. After sterilization, adequate time should be allowed for the dispersal of residual ethylene oxide and other volatile residues.


STERILIZATION BY IONIZING RADIATION Sterilization of drug substances, dosage forms, materials and medical devices may be achieved by exposure in the final containers or packages to ionizing radiation in the form of gamma radiation from a suitable radio- isotopes source such as cobalt-60 or cesium-137 or of electron energized by a suitable electron accelerator. In either case the radiation dose to yield the required degree of sterility assurance should be established such that within the range of minimum and maximum doses set, the properties of the articles being sterilized are acceptable.


CONCLUSION Today , packaging technology has been developed in order to add an attractive appearance and gain more market share for food products. The consequence of using nonessential packaging materials is only to increase the cost. Furthermore, it causes environmental pollution. The packaging should function well in protecting and maintaining fresh quality, be safe and attractive to the consumers, environmentally friendly and use less-expensive materials. In competitive markets, cost is obviously an important factor. This applies to the packaging material and packaging operations, and has resulted in the adoption of plastic containers instead of metal and glass; also flexible, laminated aseptic packs have replaced cans and bottles of juice, at about one-third of the cost.


REFERENCES Banker,G.S;Rhodes C.T. ;Modern Pharmaceutics “Packaging of Pharmaceutical dosage form, 4 th edition,revised,2002, page no.587-610 Winfield, A.J., Richards, R.M.E, Pharmaceutical Practice, 3 rd edition, 2004, page no. 105-115; Lachman, L; Liberman, H.A; Kanig, J.L.;Packaging material sciences, 32 th edition1990, page no.711-730; Williams Lippincott Remington “Plastic packaging materials”;21th edition vol.1, page no.1005-1014-1054;2005 Williams Lippincott Remington “Plastic packaging materials”; 20 th edition, page no. 1005-1014,2000 Allen, Loyd V.; Popovich Nicholas G, Ansel ; Howard, C.Ansel , “Packaging, labeling, storage of pharmaceuticals” 8 th edition ,2005 , first Indian reprint 2007, page no.80-91,. Mehta, R.M. “Containers and closures for dispensed products reprint edition 2007 page no.49-65 (dispensing pharmacy );

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Mehta R.M. p’ceutics -I, “Packaging of pharmaceuticals”, reprint 2006, III-edition pages-75-89; Cooper and Gunn’s, 8 TH edition, ,steritization-541-693; Packaging and labeling page no.189,696-698 Gokhale,S.B .; Parakh S.R., kasture , P.V.; Hasan S.A. “Packaging of pharmaceuticals”, 13 th edition, 2006, page no. 4.1-4.16 Jain, U.K.; Gopale D.C.; Nayar S. “pharmaceutical technology”, I edition-2008;page no. 1-20,83-101,115-134, 141 Indian Pharmacopoeia vol -I, 1996, page no1125

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A Look at solution to O-T-C tamper packages engineering.Cahners,vol 27,no.13,December 1982. Wikipedia Studied the primary components of a sterilization 2009 Harburn K. “Quality Control Of Packaging Material In Pharmaceutical Industry” published by repilika Press Pvt Ltd First reprint 2005. Page 85, 133 Alastair H. “ An article on Minimum packaging technology for food” published by FAO Regional office for Asia and the Pacific Bangkok, Thailand Page 2-3 Jacobs, GP,” Radiation sterilization of pharmaceuticals” Radiation Physics and Chemistry [RADIAT. PHYS. CHEM.]. Vol. 26, no. 2, pp. 133-142.1985 Kenneth C, Roger C, Karen M.” Stabilization of pharmaceuticals to oxidative degradation” in journal “Pharmaceutical development and technology”   by Informa Healthcare, New York, NY, ETATS-UNIS 1996 pp. 1-32 Boess C.; Bogl K. W. “Influence of radiation treatment on pharmaceuticals” in journal “Drug development and industrial pharmacy   “ by Taylor & Francis, Colchester, ROYAUME-UNI  1996, vol. 22, n o 6, pp. 495-530

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Wekhof et “Sterilization of Packaged Pharmaceutical Solutions” by Published in Proceedings of the Second International Congress on UV Technologies, July 9-11, 2003 , Vienna, Austria Keitch L. smith “Design of a sterilizer relies within the customer’s” , National instt.of packaging.1990 Wheaton, I.L,”a review on Spray technology of packs. June 23,24 2008 Paul Hook, Joe. Heimlich an article on sterility pack .1690, Jain U.K “sterility packs and packaging material.” National instt . of packaging.1990 Brody A. L, and Marshm K, S, "The Wiley Encyclopedia of Packaging Technology" 1997 Wilmington, D.E.; Montesino Associates, a report on LLC and Prodieco Pharmaceutical ltd. 2004 Thomason,W.A;Education , “Sterility Pack Dramatically Improve Medication Compliance”, the Journal of the American Medical Association.2006

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