Validation of packaging operations
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Validation of packaging operations

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Validation of packaging operations Validation of packaging operations Presentation Transcript

  • Presented By : Anchal Kesari M.Pharm. (QAT) Guided By : Mr. Mukesh T. Mohite (Asstnt. Prof.) Padm. Dr. D.Y. Patil College of Pharmacy, Akurdi Pune-44.
  •  Introduction  Selection criteria for packaging material  Characteristics of packaging material  Types of packaging  Types of packaging materials  Validation Protocol  VMP  Sampling and testing  Q.A. aspects  Blister Packaging  Strip Packaging 2
  • Definition 3 Packaging : may be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use. Packaging Validation : to confirm that the resulting product from a specified packaging process consistently conforms to product attributes & requirements.
  • 4 Selection Criteria Product Content Need of Protection Product Application Content Reactivity
  • 5 •Must meet tamper-resistance requirements •Must be FDA approved •Must be non toxic •Must not impart odor/taste to the product •Must not reactive with the product •They must protect the preparation from environmental conditions
  • 6 1. Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. Eg: Ampoules,Vials ,Containers ,Syringe ,Strip package, Blister packaging.
  • 7 2. Secondary packaging is outside the primary packaging – perhaps used to group primary packages together. Eg: Paper and boards, Cartons
  • 8 3. Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers.
  • Apart from primary and secondary packaging, two types of special packaging are currently in use, as follows:  • Unit-dose packaging. This packaging guarantees safer medication by reducing medication errors; it is also more practical for the patient.  • “Device” packaging. Packaging with the aid of an administration device is user-friendly and also improves compliance. This type of packaging permits easier administration by means of devices such as pre-filled syringes, droppers, transdermal delivery systems, pumps and aerosol sprays. Such devices ensure that the medicinal product is administered correctly and in the right amount.9
  •  I) Glass  II) Metals  III) Rubbers  IV) Plastics  V) Fibrous material  VI) Films, Foils and laminates 10
  • 11 Packaging Materials ADVANTAGES DISADVANTAGES GLASS • suitable for sterilization • relatively non- reactive • easily labeled • relatively heavy • fragile so easily broken METALS Impermeable to moisture, gases, odors, light, bacteria, and shatterproof • Liable to corrosion • Less flexible. RUBBERS Used to form closures • Risk of product absorbing on or in to a rubber. • Has certain degree of moisture & gas permeation PLASTICS • Flexible • No risk of breakage • Light in weight • Not chemically inert • May possess an electrostatic charge which will attract particles. FIBROUS MATERIAL Provides physical protection especially to items like metal collapsible tubes FILM, FOILS and LAMINATE • can extend the storage period of drugs. • suitable for packing moisture-sensitive drugs
  •  Short description of the process with a summary of the critical processing steps or critical parameters to be monitored during validation.  Additional testing intended to be carried out e.g. with proposed acceptance criteria and analytical validation as appropriate.  Sampling plan — where, when, how and how many samples are taken.  Details for recording and evaluation of results. 12
  • The change control process used Validation Master Plan will include key elements of the validation program-  Company’s validation policy  Organizational structure of validation activities  Summary of facilities, systems, equipment and processes validated/to be validated. All critical equipment, systems, devices, software must be identified and listed.  Defines nature & extent of testing, test procedures  Documentation format (e.g. protocol and report)  Planning and scheduling  Change control process 13
  •  Sampling :  To check the correctness of the label, packaging material or container references.  Detecting adulteration of the medicinal product.  The sampling procedure should be described in a written protocol.  Testing : Visual inspection (cleanliness, defects) Tests to identify the material  Dimensional tests  Physical tests Chemical tests  Microbiological tests 14
  •  To ensure that patients and consumers receive high-quality drugs.  The quality management system must take the following considerations into account if the required quality of packaging is to be obtained:  — the requirements of the national authorities and the relevant legislation  — the product  — the production process  — the manufacturers’internal policies (safety, marketing, etc.).  Bad packaging which is the result of deficiencies in the quality assurance system for packaging can have serious consequences, and packaging defects can create problems15
  • Blister pack: “Blister pack or bubble pack is a term for several types of pre-formed plastic Packaging used for small consumer goods, foods, and for pharmaceuticals” Blistering: “Blistering is the process of making Blisters or enclosing the tablets & capsules into preformed plastic packing” 16
  • 17 The four basic components of pharmaceutical blister packages are; • The forming film (Forming films account for approximately 80–85% of the blister package) • The liding material (liding materials make up 15–20% of the total weight of the package) • Heat seal coating • The printing ink
  • 18 Heating the plastic Thermoforming it into blister cavities Loading the blister with the product Placing lidding material over the blister Heat-sealing the package I) Thermoform Blistering machine: Example : ALU-PVC machine
  • 19 FIG 2: Thermoform Blistering Machine
  • 20 II] Cold Forming Blistering machine: Example: ALU-ALU Machine Operation sequence involves; Installing the Aluminium Foil Cold forming it into blister cavities via punch pins Loading the blister with the product Placing lidding material over the blister Heat-sealing the package
  • 21 1. Bottom foil uncoiler 6. Cover foil uncoiler 11. Discharge conveyor 2. Cold forming station 7. Cooling & slitting 3. Feeding device 8. Draw Off 4. Empty checker 9. Punching 5. Sealing & Embossing 10. Waste foil coiler
  • 22 III] Thermo-cold forming blistering machine: Eg: ALU-Tropical Machine Operation: The Operation sequence involves; Heating the plastic Thermoforming it into blister cavities Loading the blister with the product Placing liding material over the blister Heat-sealing the package Installing the aluminium foil Cold forming it into blister Pouch & seal it on thermoformed blister to give extra protection Cutting into individual blisters
  • 23 FIG 3:Thermo-cold forming Machine
  •  It 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 before forming the final set of seals. A continuous strip of packets is formed which is cut to the desired number of packets in length.  The materials used for strip package are cellophane, polyester, polyethylene, polypropylene,24
  •  Industry  Constantly challenged to reduce costs  New markets and new packs add complexity to the operation  An ever changing regulatory environment demands compliance.  To ensure pack integrity, manage complexity, maximize efficiency and minimize costs; appropriately designed packs, running in validated packaging lines, are a business necessity rather than a regulatory requirement.  If validation is well planned and documented, then GMP 25
  • Visible costs e.g., waste, returned / recalled goods …………………………… …………… …… Invisible/Hidden costs e.g., wrong decisions, non- trained workers, Non-standardized process,unsuitable 26
  • 27 Quality is designed and built into the process/method/equipments/premises Functionality, consistency and repeatability is confirmed by Validation
  •  Pharmaceutical Process Validation, Third Edition, Ira R.Berry & Robert Nash, Marcel Decker Inc.  Pharmaceutical Validation Master Plan by Syed Imtiaz Haider, St. Lucie Press  www.ijpqa.com  www.pharmaceuticalvalidation.blogspot.in 28
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