1 / 39

LECTURE CONTAINERS, CLOSURES AND THE PACKING MATERIALS USED IN PHARMACY

LECTURE CONTAINERS, CLOSURES AND THE PACKING MATERIALS USED IN PHARMACY. Plan of the lecture: 1. Classification of containers. 2. Classification of closures. 3. Packing materials. 4. Requirements to containers, closures and packing materials.

aulani
Download Presentation

LECTURE CONTAINERS, CLOSURES AND THE PACKING MATERIALS USED IN PHARMACY

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. LECTURE CONTAINERS, CLOSURES AND THE PACKING MATERIALS USED IN PHARMACY Plan of the lecture: 1. Classification of containers. 2. Classification of closures. 3. Packing materials. 4. Requirements to containers, closures and packing materials. 5. Storage of containers, closures and packing materials.

  2. Classification of containers By functional purpose Consumer (retail) container Transport container Initial (immediate) Secondary (outer)

  3. By turnover Single-use Reusable By materials used Glass, polymeric, metal, cardboard, wooden, combined

  4. By shape Cylindrical conic Round and oval in section Tetrahedral containers of complex design By rigidity Rigid Soft

  5. By capacity Consumer (retail) Transport (shipping) Small, average, large Small-sized, large-sized

  6. By method of manufacturing Blown Stamped Pressed Thermoformed Glued Moulded

  7. By volume Full Nominal By color Transparent, opaque, white or painted

  8. By design features Consumer (retail): Vials with ground neck, jars,bottles, vials, aerosol cylinders, tubas, blister packages, packs,parcels, boxes, cases,test tubes, cans Transport (shipping): Boxes, barrels, canisters, drums, cylinders, trays, cans, baskets, sacks Folding, nondemountable, collapsible. Open, closed, crate

  9. Classification of glass retail containers by way of manufacturing Produced ofglass mass: Vials with ground neck, jars,bottles, vials, aerosol cylinders Produced of glass rods: Ampoules, insulin vials and vials of general purpose, carpules, syringes, jars with triangular nimbus

  10. Classification of retail containers by design features Jar - is retail container mainly with cylindrical body, with a mouth which diameter is equal to diameter of a body or slightly less, with flat bottom, having capacity from 0,025 up to 10,0 litres. Vial – is retail container with flat or concave bottom, with a body of various shape which sharply narrows into a mouth which nimbus diameter is much less than diameter of a body. Mouth is to be sealed with a stopper and/or a cap. DSTU 2890-94

  11. Classification of retail containers by design features Bottle - is retail container mainly with cylindrical body having flat or concave bottom and a narrow mouth, designed for sealing. Wall of a body usually has a measuring scale. Ampoule - is single-use retail container with cylindrical body with flat or convex bottom and extended mouth, hermetically soldered after filling production therein. DSTU 2890-94

  12. Classification of retail containers by design features Tube – is a single-use retail container with a body providing manual extrusion of inner content, with a narrow mouth, sealed with a cap, and a bottom closed after filling production therein Tubes Polymeric Aluminium Laminated DSTU 2890-94

  13. Classifying of closures Bypurpose Without first opening control With the first opening control

  14. By design features Covers – closures that being fixed close a container by the whole external perimeter of a mouth Caps - closures, put onto a mouth of a container after its corking in order to protect it from undesirable opening Tube covers - versions of covers, screwed onto outlet neck of tubes

  15. Stoppers (plugs) - are to be inserted or screwed inside mouths of a container Closures with additional functional adaptations (spraying, dosing, smearing, dispersion)

  16. By method of fixing onto container Screwed Pulled-on Rolled-on Inserted

  17. By materials Glass Combined Rubber Plastic Cork Metal

  18. By method of sealing and sealing materials With linings With germetics or elastic materials Fixed by welding or glueing By method of manufacturing Stamping Stretching Pressing Moulding under pressure

  19. Requirements to containers, closuresand packing materials General Special Sanitary- hygienic

  20. General requirements Protection from mechanic and physico-chemical influences Operational Package should be easy to open and close; should provide easy withdrawing of contents being in any aggregative state; should be attractive, informative Consumer Should provide easy transportation of goods, application of automatic sealing equipment; should have corresponding sizes providing convenience in use and compactness Technological

  21. Modern requirements for packing materials and containers • should be permitted for use by National (e.g. Ukrainian) MoH and have corresponding registration certificate !!!; • should conform requirements of the acting normative (reference) documentation; • for manufacturing of package only materials which do not influence stability and pharmacological properties of drugs should be used.

  22. Within materials of initial (immediate) containers presence of belowmentioned agents is prohibited: - As, heavy metals and other harmful impurities in quantities exceeding those indicated in authorized specifications; - dyers which can react with a drug; - cancerogenic substances and toxic components; - foreign smell; - damage of surface protections of a container; - mechanic pollutions; - microorganisms on surface of a container in quantities exceeding those stated in requirements of the corresponding RD.

  23. The design of initial package should provide: - protection of drugs against influence of environment; - prevention of mechanic influence; - tightness and stability; - reliable protection from microbic contamination; - dosed or single-unit withdrawing of a drug; - if necessary, provide the first opening control and safety of a product; - attractive appearance and convenience in use.

  24. In SPhU 1.1 (in EP 5) the following packaging materials are recommended for drugs: Glass: of 4 grades, depending on hydrolytic resistance Plastic: Polyethylene terephtalate Low density polyethylene Polypropylene High density polyethylene Polyvinylchloride These materials are recommended by SPhU and EP to use in production of packing for medical products. Choice of a material depends on properties of a dosage form. For production of packing for medical products other materials can be also applied, but their application should be authorized by MoH of Ukraine.

  25. Technical requirements showed to glass containers Container should correspond requirements of State Standards and Pharmacopoeia of Ukraine Onto surface and within glass there should not be: Chips Cracks Chemical and thermal stability Seeds Foreign inclusions Surface should be smooth Cord, manually sensitive Bruise

  26. Technical requirements showed to metal containers (of aluminium) Internal surface should be covered with special varnish External surface should be enameled according to RD Enamel and printed paints should be water-resistant

  27. Technical requirements showed to polymeric containers Items of plastics should not have the following defects: Cracks Undermoldings Swellings Stains Bowls Deformations and joints Large foreign inclusions

  28. Edges of items should be Equal, smooth Without sharp sides No cracks andagnails Surface of items should correspond requirements of RD Materials, used in manufacturing thereof should be harmless

  29. Package, marking, shipping Package The gross weight of packed place should not exceed 15 kg. In each box one should put packing list with indication of: The enterprise-manufacturer The name of container or symbol Date of package Number of the packer and the controller of Quality Department Quantity of items Number of RD

  30. Marking of retail container According to DSTU 4260:2003 and GOST 30288-95 marking is stamped onto a bottom or onto walls of container near the bottom part of a body. Marking should contain the following elements: 1. A print of the trademark or code of the enterprise - manufacturer; 2. Nominal capacity (ml / l); 3. Year of manufacture (two last digits); 4. Number of a compression mould (if container is manufactured by method of pressing). 5. Material used in manufacturing of the container

  31. In Ukraine in 2004 the Standard DSTU 4260:2003 started. Тара і паковання спожиткові. Марковання. Загальні вимоги.This one regulates marking of retail container depending on its material. Moebius loops designating, that the container can be subjected to secondary processing or produced of the recycled raw material. The material is designated by alphabetic symbols and list number.

  32. Marking of containers of glass rod Each box is marked with a label, on which the following info is specified: The enterprise - manufacturer The name of an item or symbol Quantity of items The following signs are applied: "cautiously, fragile!" "not to be tipped!" “do not throw!" "top!"

  33. Classifying of packing Materials Bypurpose By materials By types For powdery, tabletted, plastic drugs, etc. Paper, cardboard, polymeric, metal (aluminium foil), combined Sheet, film, corrugated

  34. By quantity of layers Single-layered Multilayered By way of manufacturing Extrusion Calendering Casting Pressing

  35. Assortment of packing materials Film polyethylene (PE) Filmpolypropylene (PP) Film polyvinylchloride (PVC) Foil aluminium varnished Film combined polyethylene-cellophan (PC) Paper with polyethylene covering (PPC)

  36. Assortment of packing materials Film polyamide (PA-1) Paper for labels Three-layer film of paper, foil, polyethylene (PFP) Parchment (grade B) Wrapping paper (grade A and B) Sub-parchment (grades ПБ, ПБ-1)

  37. Marking of transport containers Handling signs Basic inscriptions Additional inscriptions The name of consignee The name of the sender The name destination point The name of the departure point Quantity of cargo places in a batch Inscriptions of transport organizations

  38. Storage of containers, closures and packing materials Store and transport only in package according to RD Store in dry aired premises Protect from influences of atmospheric deposits, direct solar beams and mechanic influences

  39. Polymeric containers: at t 10-15◦C, in dry ventilated premises on distance not less than 1 m from heating appliances Glass containers: in dry aired premises, protecting from influence of atmospheric precipitations Wooden, cardboard and a paper containers: at 18-20◦С, protect from humidifying Metal containers: protect from corrosion Rolled packing materials: store in vertical position

More Related