Legal and official requirement of container, packaging

Here we discuss, the following subject topics
1. Official and legal requirements of container
2. Types of packing
3. Material used in packing or container
4. Label
5. Labelling techniques

1. MAHARSHI DAYANAND UNIVERSITY Department of Pharmaceutical Sciences, Rohtak TOPIC : LEGAL AND OFFICIAL REQUIREMENT OF CONTAINER

2. A pharmaceutical packaging (container) is the means of providing protection, presentation, identification, information, and convenience to encourage compliance with a course of therapy. Composition of package : Container Closure labelling Carton or outer box

3. QUALITIES OF GOOD CONTAINER : The container must be neutral towards the material which is stored in it. The container must not interact physically or chemically with the substance which it holds. It should help in maintaining the stability of product against the environmental factors which causes its deterioration. It should be able to withstand changes in pressure and temperature. The materials used for making of the container must be non-toxic. It should be made of materials which can withstand wear and tear during normal handling. Vibration - Usually due to transportation Compression - this usually includes pressure applied during stacking. Shock - such as impact, drops or rapid retardation. Puncture - penetration from sharp objects or during handling operations. Abrasion - this may create electrostatic effects. 7. They must be FDA (Food & Drug Administration) approved. 8. They must meet applicable tamper-resistance requirements.

4. TYPES OF CONTAINERS: Containers are divided into following types on the basis of their utility - Well – closed containers : A well-closed container protects the contents from loss during transportation, handling, storage or sale. Multi dose containers : These containers allow the withdrawal of dose at various intervals without changing the strength, quality or purity of remaining portion. these containers hold more than one dose. Light-resistant containers : These containers protect the medicament from harmful effects of light. These containers are used to store those medicaments which are photo-sensitive. Air-tight containers : These are also called hermetic containers. These containers have air-tight sealing or closing. These containers protect the products from dust, moisture and air. Where as air-tight sealed containers are used for injectables , air-tight closed containers are meant for the storage of other products. Aerosol containers : These containers are used to hold aerosol products. These containers have adequate mechanical strength in order to bear the pressure of aerosol packing.  Single dose containers : These containers are used to supply only one of medicament and hold generally parenteral products. E.g. ampoules and vials 14

5. Materials used for forming films (blisters) : 1. Polyvinyl chloride/polyethylene combinations 2. Polystyrene 3. Polypropylene 4. Polyvinyl chloride (mostly used) Blister packaging is a type of packaging produced by heating a sheet of plastic and moulding it into shape to form a bubble or pocket the 'blister' that completely covers the product. Alu-alu packaging : Alu-alu packing means aluminium foil at both the upper and lower side of pack. Alu - alu packaging is similar to that of blister packing the only difference is that the forming film is formed of aluminium foil instead of plastic material. Strip Package : A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping rollers. This package is used for both capsules and tablets.

6. TY

7. https://www.slideshare.net/PrincyAgrawal6/pharmaceutical-container-and-closure-an-overview Lachman and leiberman’s , The theory and practice of Industrial Pharmacy, Fourth Edition,CBC publisher and distribution, page no. : 1034 https://oaji.net https://www.reseachgate.net