Packaging Material industrail pharmacy.pptx

Industrial pharmacy packaging

1. Packaging Material

2. Presented by: Dr. Sikandar talib (47) Dr. Nouman malik (18) Dr. Tanzeel ul rahman (78) Hamid mustafa (93) Ali Asim (50) Presented to: Dr. Momina Zia

3. Packaging Material: Packaging material means any material, container or wrapping, used for or in connection with the transport ,handling ,protection , marketing or sale of any supplies ,excluding any material ,container or wrapping used for the containment of the supplies.

4. Types of packaging : Primary packaging: It is the packaging in a direct contact with the product itself and it sometime refers to as consumer unit . Secondary packaging: It is the packaging used outside of primary packaging to group a certain number of products to create a stock keeping unit . Tertiary packaging : It is the packaging used to group larger quantities of SKUs to transport them from production facility to point of sale .

5. Classification of packaging material : Glass Plastic Rubber Metal

6. Glass: Glass has been used as a drug packaging material Glass is composed of sand, ash and limestone. Al, Na, K , Ca, Mg ,Zn and Ba are generally used into the preparation of glass Advantages : They are hygienic and suitable for sterilization They are transparent and easily labeled . Disadvantages: Relatively heavy and easily broken Release alkali to equeous preparation .

7. Metals: Metal containers are used for the medicinal products for the non parental administration . The metal commonly used for this purpose are aluminum, tin plated steel, stainless steel ,tin and lead . Advantages : Light in weight comparable to glass containers. Impermeable to light ,moisture and gasses. Disadvantages : They are expensive. T hey react with certain chemicals.

8. Rubber: Rubber is used for the construction of closures meant for vials, transfusion fluid bottles and dropping water . Advantages : Water absorption is very low Relatively cheaper . Disadvantages : Oil and solvent resistance is not very good . Slow decomposition takes place above 130 degree Celsius

9. Plastics : It is defined as any group of substances of natural or synthetic origins consisting chiefly of polymers of high molecular weight that can be moulded into a shape or form by heat and pressure . Types of plastics : Thermoplastics: These are softened by heat and can be moulded . For example polypropylene and polystyrene . T hermosets plastics : T hese are formed by heat process but are then set and cannot change shape by reheating. F or example polyesters and epoxy resins.

10. Advantages : Less weight then glass Flexible Variety of sizes and shape Extremely resistant breakage . D isadvantages: Poor printing A bsorption permeable to moisture

11. Factors influencing the choice of packaging The product: The physical and chemical characteristics of the drug entity, the excipients, the formulation, types of patient( baby, child, teenager, adult, adults, infants etc.) must be considered while dealing with the pharmaceutical product apart from the properties of drugs, package style to attract patient and other legal requirements should also be considered during selection. The Market: The channel of sale should be considered. i.e , where, when, how and by whom it is to be administered or use ( i.e , Doctor, dentist, nurse, patient etc.), wether for home trade and/ or export.

12. The distribution system: The distribution system should be carefully monitored, e.g conventional wholesale/ retail outlet or direct or selective outlet less sophisticated transport system like mules, donkeys camels etc. require additional protection if intermediate storage facility are non existence. Manufacturing Facilities: The stability of the manufacturing facilities should be considered due to new package, increase sale, improvements in good manufacturing practice, revised product, or new product etc.

13. Attributes of packaging material : Must be FDA approved. Must be non toxic Must non reactive with the product Must meet tamper resistance requirements Must protect the preparation from environmental conditions Must not impart odor or taste to the product

14. Stability testing of packaging material : Compression strength testing: Packaging behave differently when expose to compressive forces . It uses testing capabilities to apply compressive forces to packages and products and provide a comprehensive report with data on the strength of a package. Package integrity testing : These test include dye leak ,visual inspection ,vacuum leak and bubble leak testing to inspect the package’s integrity capabilities.

15. Package strength testing : It is conducted to measure and ensure that the components of package will not separate when specific forces are apply. vibration testing : Packages and products experience a wide range of dynamic forces and stresses during distribution that could harm a product . Shock and vibe testing : Dropping ,rotational edge dropping and rotational flat drop test to stimulate real world exposure of package to shock forces by fork lift ,package handling are others factors in the pharmaceutical package’s distribution .

16. Packaging line A packaging line is a automated production line on which finished products are packaged to protect them during shipment and handling before use. A packaging line typically includes several stages, such as sorting, filling, sealing, labeling, and boxing.

17. Types of packaging line Straight line U-shaped line The choice of straight lines or U-shaped lines can be made only on the basis of department layout or line speeds. If U-shaped lines are selected, essential materials-handling activities that are not related to actual filling or labeling, for both the input and output sides of the U, should be performed outside the department (Fig. 26.20). This arrangement not only eliminates noise, heavy traffic, and paper dust, but also helps to reduce air-conditioning loads in the packaging department. U-shaped lines with bottle filling and case sealing external to department. Distance between lines is 15 ft, and a divider can be used for separation

18. Straight packaging line when needed Straight packaging lines , on the other hand, do not lend themselves to such an arrangement, since the output end of the line must be provided with shipping cases and case-sealing machinery, and all finished products must be carried out of the room with lift trucks

19. labeling . For operations in which there are considerable numbers of labels of the same size or color, the concept of roll labeling equipment versus cut labels should be explored carefully. Roll labels have many advantages over cut labels in avoiding mislabeling or label mixups in either the label-printing operations or the storage and handling of labels in packaging. As the name implies, when the continuously printed sheet of labels comes off the printing ress , it is slit, and each row of labels is wound into a roll around a center spool. Each label also has an identifying mark on it that not only provides correct label identification, but also allows electronic counting, thereby permitting good label reconciliation.

20. If cut labels must be used, label-scanning equipment should be provided for label identification either before the labeling operation, at the labeling machine, or at both times. Labels should be stored in an air-conditioned room, and in winter, the air should be humidified to maintain a relative humidity of about 50% to avoid overdrying of labels. The room should have sufficient space for storage of inserts and be subdivided to separate approved from unapproved labels and inserts in accordance with GMP.

21. The department should be equipped with an adequate number of sinks to permit washing of measuring utensils such as graduates and packaging line equipment parts. Usually, one sink is sufficient for two lines. The cleaning of dry products filling equipment by vacuum or compressed air should be conducted during shutdown hours when the danger of cross contamination is minimized. Whenever compressed air is used for cleaning, the equipment should be removed from the line if possible or completely enshrouded during the cleaning operation. Space should be available for use by departmental and/or quality control line inspectors for the storage of counting boards, graduated cylinders, torque testers, and other in-process testing equipment; also, cabinets should be provided for clean utensils and parts. A staging area should be available for the storage of packaging equipment not in use and machine change parts, and facilities for cleaning and dismantling packaging equipment should also be provided.

22. Advantages of a Packaging Line Efficiency : Automated packaging lines can significantly speed up the packaging process, allowing companies to pack a higher volume of products in a shorter amount of time. Consistency : Automated packaging ensures uniformity in the packaging process, which is crucial for branding and product quality. Cost Savings : While the initial investment might be high, over time, automated lines can reduce labor costs and increase productivity, leading to overall cost savings. Reduced Labor Requirements : Automation reduces the need for manual labor, which can lead to fewer workplace injuries and a smaller workforce to manage. Flexibility : Modern packaging lines can often be adjusted to handle different products, allowing companies to easily switch between products. Quality Control : Many packaging lines include integrated quality control systems that can detect defects or inconsistencies in the packaging process.

23. Disadvantages of a Packaging Line High Initial Investment : Setting up a packaging line can require significant capital investment, especially for automated systems. Maintenance Costs : Automated packaging lines may require regular maintenance and repairs, which can incur additional costs. Complexity : Operating a packaging line can be complex, requiring trained personnel to manage and troubleshoot the equipment. Risk of Downtime : Equipment failures can lead to significant downtime, impacting production schedules and costs. Limited Customization : Automated systems might lack the ability to customize packaging for specific customer needs compared to manual processes.

24. ALLAH HAFIZ