InstantGMP Compliance Series - Facility Design
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The design of facilities used in the manufacturing of dietary supplements must meet strict requirements for preventing mix-ups and cross contamination. This presentation describes how this can be done.
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InstantGMP Compliance Series - Facility Design
- 1. InstantGMP Compliance Series for cGMP Dietary Supplements Facility Design
- 2. Facility Design Principles • Design should focus on meeting future production needs • Storage areas should be optimized for flow, cleanliness and prevention of cross- contamination • All areas should be labeled for intended use • Design of walls, floors, ceilings, ledges, drains, air supply, should prevent build-up of dirt and dust to avoid unnecessary risks of contamination Electronic cGMP Manufacturing Execution System
- 3. Premises Considerations • Location • Design • Construction • Adaptation • Maintenance Electronic cGMP Manufacturing Execution System
- 4. Location • Geography, climate, noise and economic factors • Neighbours – What do they do? – What impact can they have on the business? • Pollution/effluent control • Minimize risk for contamination of products Electronic cGMP Manufacturing Execution System
- 5. Layout and Design • Minimize risks of errors • Permit effective cleaning • Permit effective maintenance • Avoid cross-contamination, build-up of dirt and dust • Avoid any adverse effect on the quality of products Electronic cGMP Manufacturing Execution System
- 6. Facility Flow • Process flow – ensure the sequence of production events prevents cross-contamination • Material flow – ensures routing of materials through plant does not promote mix-ups or confusion about their status • People flow – how people move around the plant should be planned to prevent crossing of critical activities or materials Electronic cGMP Manufacturing Execution System
- 7. Small Scale GMP Manufacturing Facility Material flow 7
- 8. Construction • Suitable materials to ensure proper cleaning • Consistent, reliable electrical supply • Suitable lighting (especially for visual on-line checks) • Temperature and relative humidity control • Appropriate and effective ventilation • All these may affect products during manufacture or storage Electronic cGMP Manufacturing Execution System
- 9. Walls, Floors, Ceilings • Walls, floors, ceilings – smooth and easy to clean • No ledges or areas where dust can accumulate • Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination Electronic cGMP Manufacturing Execution System
- 10. Avoid Cross-Contamination • Special precautions should be taken to prevent generation and dissemination of dust • Proper air control – supply and extraction, suitable quality • Prevent uncontrolled release of dust, gas, particles, vapours, sprays, organisms, residue, insects Electronic cGMP Manufacturing Execution System
- 11. Ventilation systems and airlocks • Appropriately designed ventilation system with air supply and extraction systems • Supply or incoming air should be filtered • Recirculation of air versus 100% fresh air supply • Proper airflow patterns • Pressure differentials • Appropriately designed airlocks Electronic cGMP Manufacturing Execution System
- 12. Closed processing systems • For example: totally enclosed water purification systems • Tanks fitted with appropriate filtration - without removable lids • Clean-in-place (CIP) systems Electronic cGMP Manufacturing Execution System
- 14. Room Log 14
- 15. Room Log 15
- 16. InstantGMP™ Find more videos on cGMP Compliance for Dietary Supplements in the Resource Center at www.instantgmp.com
Hinweis der Redaktion
- The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the documentation of GMP procedures.
- The basic design principles for any facility should focus on the intended production uses. Storage areas should be well organized and optimized cleanliness, good maintenance and prevention of cross contamination The areas should be well labeled and materials stored in a such a way as to avoid any risk of cross-contamination. Walls, floors, ceilings, ledges, drains and air supply, should be designed to prevent build-up of dirt and dust to avoid unnecessary risks of contamination.
- There are several things to consider when designing the premises. The land and buildings where the manufacturing operations are located must contribute towards the quality of the products. The design and the construction must avoid the risks of contamination, permitting effective cleaning and maintenance, minimizing the build-up of dirt and dust and preventing quality defects. We will look at each of these areas in more detail.
- The geography of the chosen location can have a considerable impact upon the design of facilities. For example, if the location is subject to environmental hazards such as flooding or there are problems with continuity of supply or services, another location may be a better option. The neighbourhood is also important. If the company is to be located next to a mill then the design precautions that it will have to take, and the level of maintenance that it will have to undertake, will be very different than if it is in a rural setting. If the neighbours change, the company will need to take appropriate measures to handle the situation correctly. The company is also required to take measures that prevent the factory polluting the surrounding area with product or by-products from its manufacturing processes.
- The land and buildings where the manufacturing operations are located must contribute towards the quality of the products. They do this by avoiding the risks of contamination, permitting effective cleaning and maintenance, minimizing the build-up of dirt and dust and preventing quality defects.
- Process flow design consideration take into account the sequence of events so that processes do not contribute to the potential for mix ups or cross-contamination. For example, dusty milling operations should be segregated from final product operations. Material flow is shown on the plan of the factory as the routing of materials throughout the facility. It is important to show the status of the materials as well. This means indicating whether they are quarantined, approved or rejected, and also the volume, weight or frequency of movement, and the way in which the material is to be moved. There should be no cross-flow of materials. People flow: A plan of the factory showing the routing taken by people when they enter the factory, when they move around in the factory from one department to another, and when they leave the factory. People should be limited to those areas where they have their activities. Production areas should not be used as passages or corridors for non-essential personnel movement.
- This plan shows the flow of material and personnel in a small scale GMP manufacturing facility. The arrows indicate the material flow, and show materials that are brought in each room through the corridor zone. The storage areas are separated from the production areas and packaging areas so there few opportunities for mix ups or cross contamination.
- Construction should be of suitable materials to ensure proper cleaning, no cracks, and that the building can withstand pressures, vibrations and other effects. The electrical supply is required for consistent performance of equipment and instruments. Where there is not a constant supply of electricity, power generators may have to be considered. Suitable lighting (especially for visual on-line checks). Temperature and relative humidity control should be provided where necessary. In many cases, materials and products have to be stored or processed under controlled conditions. The temperature and RH should be controlled, monitored in accordance with an SOP, and the results recorded. Appropriate and effective ventilation should be provided. These may affect products during manufacture or storage as well as functioning of equipment
- Walls, floors, ceilings should be smooth and easy to clean. There should be no ledges or areas where dust can accumulate. Overall, the design should prevent build-up of dirt and dust to avoid unnecessary risks of contamination.
- Special precautions should be taken to prevent generation and dissemination of dust Proper air control – supply and extraction, suitable quality Prevent uncontrolled release of dust, gas, particles, vapours, sprays, organisms, residue, insects, operators
- An important measure against cross-contamination is the design of the ventilation system. All incoming air should be filtered to an appropriate standard to achieve the grades of cleanliness specified for the room being supplied. The use of appropriate pressure differentials and air extraction, together with airlocks, is one of the main ways of achieving control over cross-contamination. The recirculation of air must be carefully evaluated. If a ventilation system supplies 100% fresh air, then different rooms can be used for different products at the same time. However, if a system includes recirculation, then all rooms supplied by that system must be processing the same product, or the air must be filtered to an appropriate standard. If no filters are installed, then all ductwork will have to be cleaned during product changeover.
- Increasingly, facilities are being designed with closed processing systems. This trend is one that should be encouraged, as it is a major element in the avoidance of cross-contamination. Some examples are totally enclosed water purification systems, tanks fitted with appropriate filtration - without removable lids or Clean-in-place (CIP) systems.
- InstantGMP provides a log where information about each of the rooms in a facility can be kept up to date.
- The room log can track all activities that are conducted in each room and keep a record of the batches that were produced in that room.
- The room log can also record the activities conducted in the room, the cleaning agent used, the batch number of the product produced there, the temperature and humidity readings and any comments or observations. This history will be particularly useful if Quality has to do an investigation or evaluate a quality issue involving product made in this room.
- This presentation is just one of many articles and videos available on cGMP compliance for Dietary Supplements. You can find the rest at the Resource Center at www.InstantGMP.com.