Parenteral Product.pptx
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The document summarizes the production procedure, facilities, and controls for manufacturing parenteral products. It involves the following key steps: 1) cleaning and sterilizing containers and closures, 2) preparing solutions by dissolving ingredients, 3) sterilizing the products through various methods like filtration or autoclaving, 4) aseptically filling and sealing the sterile containers, and 5) packaging and labeling. The facilities are designed to control the environment and prevent contamination at each step. Various controls like environmental control, traffic control, and air control are in place to maintain aseptic conditions.
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In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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Parenteral Product.pptx
- 1. Parenteral Product Mr. Amit Ashok Khune B.Pharm. PRODUCTION PROCEDURE, PRODUCTION FACILITIES AND CONTROLS, ASEPTIC PROCESSING.
- 2. No. Title Slide No. 1 Production Procedure (Aseptic Processing) 3 2 The manufacturing of parenteral involves the following steps: 5 3 Facilities 12 4 Controls 13
- 3. Production Procedure (Aseptic Processing) • The general procedure for manufacturing parenteral include planning and scheduling of equipment , material managements, and manufacturing requirements like ingredients, drugs, etc. • An overview of the manufacturing process of parenteral is shown .
- 4. Planning and Scheduling Equipment and Facility Manufacturing Requirements Documentation Visual Inspection Aseptic Filling Q.C. Testing Sterilisation Bulk Analysis Manufacturing Finishing Labelling and Packaging Warehousing Material Management 1) Raw Material and API 2) Packaging Material Personnel
- 5. The manufacturing of parenteral involves the following steps: 1)Cleaning and washing of containers and closures 2)Preparation of solutions 3)Sterilization 4)Filling and sealing 5)Packaging and labeling
- 6. 1)Cleaning and washing of containers and closures • Containers thoroughly cleaned with detergent with tap water, Then with Distilled water. • Sterilised for 4 hours at 2000c. • The closure are cleaned by boiling in detergent solution and then washed with water. • Sterilised by autoclaving 30 min. 1150c.
- 7. 2) Preparation of solutions • The API is completely dissolved in water for injection with constant stirring. • Excipients are added while stirring to completely dissolve them. • The volume is made up by adding water for injection. • The pH is adjusted by using buffering agents like NaOH & HCl
- 8. 3) Sterilization • Parenteral products are filled in sterilised container. • for sterilizing thermolabile products, non -thermal methods are used. • filtration through bacteria -proof filters • Sterilisation by radiation • Dry heat sterilization • Lyophilization (also known as freeze drying). • Autoclaving
- 9. Ampoules • After filling the ampoules they should be immediately sealed to prevent the contamination of contents. • They are sealed by melting a portion of the glass neck. • The following two types of seals are employed: • 1) Tip- or Bead –Seals • 2) Pull-Seals 4) Filling and sealing
- 10. • Vials • The vial openings are sealed with rubber closures held in place by an aluminum sealing. • A hand crimper is used to put the rubber closures and aluminum sealing onto the vials.
- 11. 5) Packaging and labeling • Packaging of parenteral products include ampoules, vials, cartridges, bottles, and bags. • The containers are made up of either glass, plastic or rubber. • The label should include all the information necessary for the physician and users to ensure safe and proper use of the product. • An add-on printed matter should be supplied to provide all the information. (If necessary.)
- 12. Facilities • designed for the control of cleanliness environment appropriate for each step. • The prevention of contamination must be the primary objective • The ceiling, walls, and floors should be easy to clean and non porous, to prevent the accumulation of debris and moisture. • Glass is used in partition to permit supervisory view of operation as well as to provide better lighted surroundings for the operators. • Furniture should be of non-porous, hard surfaced materials, preferably stainless steel.
- 13. Controls: It includes: 1. Environmental Control 2. Traffic Control 3. Housekeeping 4. Surface Disinfectant 5. Air Control 6. Personnel
- 14. Thank You!