Temper resistante. ppt
- 1. Tamper Resistant Packaging Presented By :- Jitendra K. Sonawane M.Pharm (QA) Guided By:- Dr. G. B. Patil Dept. of Pharmaceutics H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur
- 2. Contents :- ❖ Introduction ❖ Film Wrapper. 1. End folded wrapper. 2. Fin seal wrapper. 3. Shrink wrapper. ❖ Blister Package. ❖ Strip Packaging. ❖ Bubble Pack. ❖ Bottle Seals. ❖ Tape Seals. ❖ Shrink Packaging. ❖ Foil/Plastic Pouches.
- 3. INTRODUCTION ➢ The requirement for temper resistant packaging is now one of the major considerations in the development of packaging for pharmaceutical products. ➢ Temper resistant package is one having an indicator to entry in which, if missing, can seasonally be expected to provide visible evidence to consumers that tempering has occurred. ➢ FDA approves the following configurations: film wrappers, blister package, strip package, bubble pack, shrink seals, and bands oil, paper, plastic pouches, bottle seals, tape seals, breakable caps, aerosol containers.
- 4. I. Film Wrapper Film wrapping has been used extensively over the years for products requiring package integrity or environmental protection. • It has categorizes into following types : 1. End folded wrapper. 2. Fin seal wrapper. 3. Shrink wrapper.
- 5. 1. End folded wrapper:- ➢ The end folded wrapper is formed by passing the product into a sheet of over wrapping film, which forms the film around the product and folds the edges in a gift wrap fashion. ➢ The folded areas are sealed by pressing against a heated bar. The materials commonly used for this purpose are cellophane and polypropylene.
- 6. 2. Fin seal wrapper:- ➢ The seals are formed by crimping the film together and sealing together the two inside surfaces of the film seal. ➢ Fin sealing is superior than end folded wrapper with good seal integrity the over wrap can removed or opened by tearing the wrapper.
- 7. 3. Shrink wrapper:- ➢ The wrap concept involves the packaging of the product in a thermoplastic film that has been stretched and oriented during its manufacture. ➢ An L shaped sealer seals the over wrap. ➢ The major advantage of this type of wrapper are the flexibility and low cost of packaging equipment.
- 9. II. Blister Package- ➢ The blister package is formed by heat softening sheet of thermoplastic and vacuum drawing the softened sheet is released from the mould and proceeds to the filling station of the packaging machine. ➢ The semi rigid tray is previously formed is filling with tablets/capsules and lidded with a heat sealable backing material. The backing material is usually heat seal coated aluminium foil.
- 10. ➢The plastic material used includes PVC, polyethylene combination. For added moisture protection polyvinyledene fluoride or poly chloro trifluoroethylene films may be laminated to PVC. o Advantages- ✓ Unit dosage. ✓ Convenience. ✓ Child resistant. ✓ Pleasing appearance. ✓ Tamper resistant.
- 11. III. Strip Packaging- ➢ Strip package is a form of unit dose packaging that is commonly used for the packaging of tablets and capsules. A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping roller. ➢ The product is dropped into the pocket formed prior to forming the final set of seals. A number different packaging. For high barrier applications a proper polyethylene foil/polyethylene laminations commonly used.
- 12. IV. Bubble Pack- ➢The bubble pack can be made in several ways but is usually formed by sandwiching the product between a thermoplastic film and a rigid packing material similar to a sin blister.
- 13. V. Shrink Packaging- ➢ The shrink pack concept makes use of the heat shrinking characters of a stretch oriented polymer usually PVC. ➢ The heat shrinkable polymer-PVC is manufactured as a tube in a diameter slightly larger then the cap and neck ring of the bottle to be sealed. ➢ This is the placed over the bottle cap and the package through a heated tunnel, which shrinks the plastic cover around the cap, preventing the disengagement of the cap without destroying the shrink band.
- 14. VI.Foil/Plastic Pouches ➢When a product requires multi-layered packaging, manufacturers normally use foil pouches. They are used as the innermost layers of packaging. It’s very important for foil pouches to be of top quality and extremely hygienic since they are in direct contact with the packaged product. ➢Generally, foil pouches are made out of aluminum and protect the product from extreme temperatures. Additionally, foil pouches maintain a low rate of moisture vapor transmission.
- 15. VII.Bottle Seals- ➢ A bottle may be made temper resistant by bonding and inner seal to the rim of the bottle, in such a way that the product can only be attained by destroying the seal. ➢ Typically glassine liners are two ply laminations use in two sheet of glassine paper bounded together with wax or adhesive. ➢ For pressure sensitive inner seals pressure sensitive adhesive is coated on the surface of the inner seal as an encapsulated adhesive.
- 16. VIII.Tape Seals- ➢ It involves the application of glued or pressure sensitive tape or label around or over the closure of the package which is to be destroyed to obtain the product. ➢ The paper used must often is a high density light weight paper with poor tear strength.
- 17. IX.Breakable Seals- ➢These seals are used for Security purpose.
- 18. X. Sealed Tubes- ➢ Collapsible tubes used for packaging are constructed of metal, plastic or lamination of foil, paper and plastic. ➢ Metal tubes are still used for products that required high degree of barrier protection. ➢ Most of those are made of aluminum. ➢ Extruded plastic tubes are widely used for products that are compactable and limited protection of plastic.
- 19. Reference:- i. Leon Lachman, H. A. Lieberman the theory and practice of industrial pharmacy, Special Indian Edition 2009, page no- 720- 731. ii. https://www.google.com/search?biw=1360&bih=657&tbm=isch &sa=1&ei=XuuHXPWfBoH1rQGKoriQCg&q=Foil%2FPlastic+ Pouches&oq=Foil%2FPlastic+Pouches&gs_l=img.3...424386.42 4386..425guatda.com/cmx.p619...0.0..0.184.184.0j1......1....2j1..gws-wiz- img.49sLstBeha0#imgrc=cbi-YWLY6CpEKM: