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Dds Document Transcript

  • 1. Qualities of the PackageFor any packaging material 5 basic qualities are required: 1) Protection Must protect against all adverse external influences that may affect quality, such as light, moisture, oxygen,mechanical damage. Some aspects of protection are superficial, such as the wrapping of an outer carton in cellulose film to avoiddust, but the protection given to the product by the primary package is very important. 2) Identification:The package must also give clear identification of the product at all stages and, again, the life of the patient maydepend upon rapid and correct identification in emergencies.Often, the package is required to identify the manufacturer to the user by a characteristic house style. 3) Presentation:Good presentation enhances the product and attracts the consumer during storage or display. In addition, the publiccan judge the product only by the appearance of the package, so that a dignified and professional presentation willgive confidence to the user. 4) Convenience:The form of package should be such that it offers convenience at all stages of its life history and the design of thepackage should be convenient for manufacturer, for transport and storage and for the use by consumer. 5) Economic:The economics of packaging are considerable practical importance; the package cost should be minimal, providedthe previous qualities are not prejudiced. In particular, care should be taken to ensure that protection is not sacrificedsimply to reduce package costs.Package Material Properties:- • Mechanical propertiesThe materials must give the container sufficient mechanical strength to withstand handling empty, when filling, andwhen closing (all these are often performed mechanically); processing (labeling, sterilization, etc.), transports, storageand supply to, and use by, the consumer.Typical of the care in design needed in this respect are glass containers. • Physical properties:-*The container must be able to withstand heat if the processing includes the sterilization.*The surface must be capable of clear labeling, often difficult, for e.g., with plastics.*The material must protect from light, if necessary it must be ultra violet absorbent.*The container must not attract substances from product; e.g., absorption of water from creams into cardboard boxes. • Chemical properties:-The container and closure should not react together, either alone or in the presence of the product. .Substances must not be abstracted from the product, such as the loss of bactericides from injection solutions torubber. The containers or closures must not yield substances to the product; for example, alkali from glass orplasticizer from plastics.
  • 2. • Biological properties :-The materials of the containers must be able to protect the attack by the insect if this hazard is likely to beencountered.Packaging Materials • Metals  Metal containers are used mainly for dry products, due to the effect of trace metal contamination introduced by the corrosion, especially of iron.  Aluminum containers and collapsible tubes for creams and ointments.Metal foils, especially aluminum are used for sachets and unit pack of tablets • Plastics  Coming into increasing use are Phenol, urea, melamine- formamide resin as screw closure.  Polystyrene tubes for tablets  Polyethylene is widely used for flexible containers, closures, bags, etc.  Polypropylene is similar to polyethylene but it has greater transparency and better heat resistance. It is also more resistant to attack by solvent, but more expensive than polyethylene. • Glass  Type I glass (commonly known as neutral glass) offers a high hydrolytic resistance due to chemical composition of the glass.  Type II glass has a high hydrolytic resistance due to an appropriate surface treatment. Both types of glass may be used for different types of injectable preparations.  Type III glass offers only a moderate hydrolytic resistance and should be used only for non-aqueous liquid preparations or for powders for injection or for injectable preparation where adequate suitability tests have indicated that this type of glass is satisfactory or for preparations not for parenteral use.  Glass may have additives to absorb light particularly ultraviolet. • RubberIt is needed in a specialized form for closure for injection containers.The Purposes of Packaging:-Packaging and package labeling have several objectives. • Physical protectionThe objects enclosed in the package may require protection from, among other things, shock, vibration, compression,temperature, etc. • Barrier protectionA barrier from oxygen, water vapor, dust, etc., is often required.Keeping the contents clean, fresh, sterile and safe for the intended shelf life is a primary function.
  • 3. • Containment or agglomeration Small objects are typically grouped together in one package for reasons of efficiency. For example, a single strip of 10 tablets requires less physical handling than 10 tablets. • Information transmission: Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. • Marketing The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. • Security Reducing the security risks of shipment, Packages can be made with improved tamper resistance. • Convenience Packages can have features which add convenience in distribution, handling, stacking, display, sale,opening, reclosing, use, and reuse.Packaging instructions :-Following instruction:(a) the name of the product;(b) a description of its pharmaceutical form, strength and, , method of application;(c) the pack size , weight or volume of the product in the final container;(d) a complete list of all the packaging materials required for a standard batch size, including quantities, sizes andtypes, with the reference number relating to the specifications for each packaging material;(e) where the batch number and expiry date of the product have been marked;(f) special precautions .(g) a description of the packaging operation, including any significant subsidiary operations, and equipment to beused;(h) details of in-process controls with instructions for sampling and acceptance limits.Labelling:- Labels applied to containers, equipment or premises should be clear. It is often helpful in addition to thewording on the labels to use colours to indicate status (e.g. quarantined, accepted, rejected, clean). (a) the name of the drug product; (b) a list of the active ingredients , showing the amount of each present and a statement of the netcontents (e.g. number of dosage units, weight, volume); (c) the batch number assigned by the manufacturer; (d) the expiry date (e) special storage condition. (f) directions for use, and warnings and precautions that may be necessary; (g) the name and address of the manufacturer or the company .
  • 4. Labeling issuance:-a. Strict control shall be exercised over labelling issued for use in drugproduct labelling Operations.b. All excess labeling bearing control numbers shall be destroyed.c. Procedures in sufficient detail shall be employed for the issuance of labeling.III. Packaging and labeling operations: a. Identification need not be applied to each individual container. b. Identification of the drug product with a control number that permit history of Manufacture.. Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have beenremoved from previous operation. Tamper-evident packaging requirements for OTC human drug products: a. A tamper-evident package may involve an immediate container and closure system to Provide a visual indication of package integrity. b. In addition to the tamper-evident packaging feature hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology. Expiration dating:a. Expiration dates shall appear on labeling in accordance with the requirements.b. Homeopathic drug products shall be exempt from the requirements.Line clearance:-The term line clearance is used for the documented act of conducting any necessary removal of products andmaterials from a manufacturing line to prepare the line for the next production(packaging).A line clearance procedure is having three stagesReconciliation of labels:It is a method and means for reconciliation between faulty labels identified during a labeling operation and removedfrom the operation.It is plays an imp role during label issuance. It is an important to reconcile all the packaging material;Especially the over printed packing materials like labels, cartons and wrappers because it leads to misuse andproduct mix-ups if not accounted.Procedure: • On the completion of packing of particular batch determine the • Quality of labels used • Quality of labels rejected. • Labels used for quality control for testing, for control samples. • Quality used for relabeling and balance labels.