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  • BPH 4202 Pharmaceutical Technology III

    Md. Imran Nur Manik

    Lecturer

    Department of Pharmacy

    Primeasia University

  • Md. ImranNur Manik

    Md. ImranNur Manik

    Packaging Technology

    Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 1 manikrupharmacy@gmail.com; Lecturer; Department of Pharmacy; Primeasia University.

    Packaging TechnologyIntroduction

    Packaging is an economical means of providing presentation, protection, identification/information,

    containment, convenience and compliance for a product during storage, carriage, display and use

    until such time as the product is used or administered. Pharmaceutical packaging provides

    protection for lifesaving drugs, surgical devices, blood and blood products, neutraceuticals,

    powders, poultices, liquid and dosage forms, solid and semisolid dosage forms.

    Definitions

    Packaging

    Packaging is the process by which the pharmaceuticals are suitably packed so that they should

    retain their therapeutic effectiveness from the time of their packaging till they are consumed.

    It is the art and science which involves preparing the articles for transport, storage, display and use.

    Container A container may be defined as a device in which the drug is enclosed and is in direct contact with the drug.

    Closures A closure is a device which seals the container to exclude oxygen, carbon-dioxide, moisture, micro-organisms and prevent the loss of volatile substances.

    Categorically differentiating pharmaceutical packaging Primary Packaging: This is the first packaging envelope which is in touch with the dosage form or equipment. The packaging needs to be such that there is no interaction with the drug and will provide proper containment of pharmaceuticals. E.g. Blister packages, Strip packages, etc.

    Secondary Packaging: This is consecutive covering or package which stores pharmaceuticals packages in it for their grouping. e.g. Cartons, boxes, etc.

    Tertiary packaging: This is to provide bulk handling and shipping of pharmaceuticals from one place to another. e.g. Containers, barrels, etc. Materials of construction refer to the substances (e.g., glass, high density polyethylene (HDPE) resin, metal) used to manufacture a packaging component.

    A packaging component means any single part of a container closure system. Typical components are containers (e.g., ampules, vials, bottles), container liners (e.g., tube liners), closures (e.g., screw caps, stoppers), closure liners, stopper over seals, container inner seals, administration ports (e.g., on large-volume parenterals (LVPs)), overwraps, administration accessories, and container labels.

    A primary packaging component means a packaging component that is or may be in direct contact with the dosage form.

    A secondary packaging component means a packaging component that is not and will not be in direct contact with the dosage form.

  • Md. ImranNur Manik

    Md. ImranNur Manik

    Packaging Technology

    Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 2 manikrupharmacy@gmail.com; Lecturer; Department of Pharmacy; Primeasia University.

    A container closure system refers to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product.

    A packaging system is equivalent to a container closure system.

    A package or market package refers to the container closure system and labelling, associated components (e.g., dosing cups, droppers, spoons), and external packaging (e.g., cartons or shrink wrap). A market package is the article provided to a pharmacist or retail customer upon purchase and does not include packaging used solely for the purpose of shipping such articles.

    Quality refers to the physical, chemical, microbiological, biological, bioavailability, and stability attributes that a drug product should maintain if it is to be deemed suitable for therapeutic or diagnostic use. In this guidance, the term is also understood to convey the properties of safety, identity, strength, quality, and purity.

    An extraction profile refers to the analysis (usually by chromatographic means) of extracts obtained from a packaging component.

    A quantitative extraction profile is one in which the amount of each detected substance is determined.

    Purposes of packaging

    The package passes through a number of stages, beginning with the container manufacturer,

    thence to the product manufacturer, wholesaler, retailer and finally the consumer.

    Therefore the packaging should perform the following purposes

    1. Protect the contents from the environmental hazards: This includes a) Light - protect the contents from light.

    b) Temperature - withstand extremes of temperature.

    c) Moisture - withstand extremes of humidity.

    d) Atmospheric gases - protect the contents from the effect of atmospheric gases (e.g. aerial

    oxidation).

    e) Particles - protect from particulate contamination.

    f) Microorganisms - protect from microbial contamination.

    2. Protects the content from the mechanical hazards: This includes a) Vibration - Usually due to transportation.

    b) Compression - this usually includes pressure applied during stacking.

    c) Shock - such as impact, drops or rapid retardation.

    d) Puncture - penetration from sharp objects or during handling operations.

    e) Abrasion - this may create electrostatic effects.

    3. To prevent the addition or loss of its contents: This includes

    a) Protect the contents from both loss and gain of water.

    b) Protect the contents from loss of volatile materials.

    c) Must not shed particles into the contents.

    d) Must not leach anything to the contents.

  • Md. ImranNur Manik

    Md. ImranNur Manik

    Packaging Technology

    Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 3 manikrupharmacy@gmail.com; Lecturer; Department of Pharmacy; Primeasia University.

    4. Provide pharmaceutically elegant appearance: This includes

    a) In a competitive market the appearance of a package first draws the attraction of the

    consumers than its contents.

    b) Must be easy to label and thus to identify the product.

    5. Product identification

    The package must also give clear identification of the product at all stages and again the life of the

    patient may depend upon rapid and correct identification in emergencies.

    6. Convenience The form of the package should be such that, it offers convenience at all stages of its life history.

    Properties of packaging materials

    The good packaging materials i.e. the containers and closures must meet the following criteria.

    (Ideal properties of containers and closures)

    1. The material must give the container sufficient strength to withstand the extremes of temperature and pressure as well as to withstand handling while empty, while filling, closing, sterilizing, labelling, transport, storage and use by the consumer.

    2. The material should be impervious to any possible contaminants; for example solids, liquids, gases vapours or microorganisms.

    3. It should not interact with the contents. This includes migration, absorption, adsorption or extraction. e.g. Absorption of water from creams into cardboard boxes.

    4. It should protect the contents from the loss of product due to leakage, spillage or permeation.

    5. It should protect the contents from the loss of water and volatile materials.

    6. The container must not impart its own colour, test or odour to the preparation.

    7. It must not alter the identity of the product.

    8. They must be FDA (Food & Drug Administration) approved,

    9. They must meet applicable tamper-resistance requirements

    10. They must be adaptable to commonly employed high-speed packaging equipment.

    11. Must be cheap and economical i.e. they must have reasonable cost in relation to the cost of

    the product.

    12. They must be convenient and easy to use by the patient.

    13. They must be non-toxic and biodegradable.

    14. The container and closure must not react either with each other or with the preparation.

    15. Apart from all these a container and closure should be attractive in appearance and must

    have sale promotion and marketing value.

  • Md. ImranNur Manik

    Md. ImranNur Manik

    Packaging Technology

    Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 4 manikrupharmacy@gmail.com; Lecturer; Department of Pharmacy; Primeasia University.

    Shelf-life: The shelf life (t90) of a pharmaceutical product is the length of time the product may safely be stored on the dispensary shelf before significant decomposition occurs. This is important since, at best, drugs may decompose to inactive products; in the worst case the decomposition m

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