Nancy: Plant Design Flashcards
What is the purpose of designing a manufacturing process?
- Can determine the cost of the manufacture
- Form of dose (tablet, suspension)
- Formulation of API (excipient)
- Stability of formulated dose
- Sterility level
- Dictate: individual processes, packaging and order of processes
- Plant clean level, size of plant and physical layout plant
How are small molecule drugs such as tablets in delivery, orally, stability and sterility?
- Delivery: simple tablet form
- Oral: No enteric pathogens and avoid spoilage
- Stability: High, no special conditions needed
- Sterility: Raw materials likely to be clean, formulate in clean environment and equipment sanitation and QC needed
How are therapeutic monoclonal antibodies (targets specific antigens) used in injections in: delivery, parentally, stability and sterility?
- Delivery: need to be simple for direct injection and dose control
- Parental: SAL (sterility assurance level), has to be sterile
- Stability: Low, cannot be dried, must be in solution
- Sterility: Formulated antibody solution must be sterilised and have antiviral treatment before packaging
How are Eye drop drug solutions used in: delivery, ocular, stability and sterility?
- Delivery: Direct dropper or administation or multi-use dropper
- Ocular: mid level sterile
- Stability: Low, cannot be dried, needs to be in solution
- Sterility: Could design different processes depending on preference, single use disposable? Multi use?
What is the design decisions when making sterile products for a typical parental solutions?
- Manufacture and formulate
- Filter and sterilise
- Aseptic fill
- Aseptic packaging
What is the design decisions when making sterile products for a dressing, syringes that are all in plastic and paper laminated packaging?
- Manufacture and formulate
- Package
- Sterilise in bulk by gamma irradiation
What are the four key concepts plant design revolves around?
- GMP (Good manufacturing practice)
- Special building features- organisation, keeping it clean
- Importance of workers
- QA and QC (plus regulatory submission)
What is the basis of modern GMP (good manufacturing process)? (IMPORTANT)
Cannot be tested into a batch of product but must be built into each batch of the product during all stages of manufacturing
What is the main leading body that maintains the cGMP guidelines?
- WHO (world health organisation)
2. EU guide to GMP
What does plant design mainly revolve around?
Simple flow of material which:
- Controls quality (must be high quality and consistent) and safety of inputs
- Safeguards during processing
- Ensures quality is preserved after distribution (prevent cross contamination)
zones physically seperate each level of operation
What are the main sources of contamination?
- Supply chain:
All ingredients, API, excipients, water and packaging - Contact:
Equipment and people
3. People: Droplets and humans shed skin Air Dust Micro-organisms
How are sources of contamination managed in plant design?
- Building design and fittings all focussed on avoiding any material or microbial contamination
- Once all input elements are checked and recorded as:
- Clean and pure - Plant designed to keep them this way
Give examples of what the critical processing area involves?
- Blending
2. Processing fill and finish
What is the purpose of the clean area?
1, Protective envelope to minimise risk to critical area
- Sterilisation
- Compounding
What is the transition zone?
- Brings people
2. Material from external to M’ fact in controlled manner
