Quality assurance is dependent upon the design of production spaces; therefore, not only is the infrastructure of a facility important, but also the specific design of each production space. For example, the layout of the room, the types of materials used in constructing the room, the way air flows into and throughout the room(s) and each room’s environmental controls directly affect the quality of the end product, how easily you can control contamination and whether or not you are following the required regulatory guidelines.
GMPs require facilities to be designed to limit as many risks as possible, such as cross-contamination, mixed products and errors. The layout of a facility that has a properly designed pharmaceutical facility will allow for an efficient workflow, smooth operations and consistent product output.
Regulatory agencies including the FDA, WHO and EMA have provided specifications regarding how to design a GMP-compliant facility.
This article will provide you with insight into the key principles of GMP-compliant room design for pharmaceutical manufacturing plants.
- Cross-contamination between products
- Mixing up materials or labels
- Microbial contamination
- Failing to meet the requirements of regulatory agencies
A facility that is correctly designed will provide a:
- Controlled environment
- Efficient flow of materials
- Reduced potential for human error
- Compliance with applicable regulations
As such, facility design is the first defense against quality assurance violations.
Proper zoning assists with the following:
This means:
HVAC systems that are designed to do:
1. Maintain humidity and temperature
2. Control air particles
3. Prevent contamination
Some hallmarks of these systems include:
1. HEPA filter to remove particles and microorganisms
2. Using pressure differential to control the direction of airflow
3. How many air changes per hour are to be performed depending on the classification of the room
Some examples of how these hallmarks work are:
1. Areas of clean, higher pressure prevent contaminates from entering as the pressures in the area(s) is/are pushing out (therefore, transferring air out of the area); and
2. Areas with hazardous materials are kept at a lower pressure than areas without hazardous materials.
The air can be controlled through airflow control, which helps create a controlled, safe environment.
Features commonly associated with a cleanroom include:
1. Smooth, clean-able surfaces.
2. Sealed walls and ceiling
3. Minimum number of joints/corners
4. Access to and from the cleanroom limited to an airlock (i.e., control entry into or out of the cleanroom).
The classification of cleanrooms ensures that the cleanroom operates according to an established minimum standard, depending on the operation in the cleanroom.
The types of acceptable construction materials include:
Buildings constructed from poor material may lead to generation of particles and contribute to contamination.
Best Practices for Containment of GMP Compliance include:
Lighting Systems should be:
- Cleaning and maintenance ease of access
- No overcrowding
- Sufficient space between equipment items
Appropriate design of utilities (water, compressed air, gases) will reduce the potential risk of contamination.
- Rounded corners (curved)
- Flush-mounted fixtures
- Minimal edges and voids
The above design elements will aid in the reduction of the accumulation of dust and reduce the potential for the growth of microorganisms.
Parameters to be monitored include
- Temperature
- Humidity
- Particulate count
- Microbial contamination
This continuous monitoring will ensure environmental conditions remain within tolerances.
Validation consists of:
1. Installation Qualification (IQ)
2. Operational Qualification (OQ)
3. Performance Qualification (PQ)
Additional studies (for example, airflow visualization and recovery tests) are also performed. Validation provides assurance that the facility operates as designed in real-world use.
Some of the trends that are becoming more prevalent in facility room design include:
- Modular cleanrooms
- Automation/robotics
- Digital environmental monitoring systems
- Advanced contamination control methods
These new designs, systems and processes allow for greater efficiency, flexibility and compliance.
The essential element of the design of any pharmaceutical facility subject to Good Manufacturing Practices (GMP) is its physical layout. The physical layout of the facility has a direct effect on the quality of the products produced in that facility as well as on contamination control and compliance with regulations.
Pharmaceutical companies can improve the design of their facilities—thereby ensuring the safe and efficient operation of the business—by paying attention to zoning, air flow, materials and workflow.
A properly designed facility will allow for the meeting of regulatory requirements as well as an increase in productivity and consistency in producing high-quality medicines.
Regulatory agencies including the FDA, WHO and EMA have provided specifications regarding how to design a GMP-compliant facility.
This article will provide you with insight into the key principles of GMP-compliant room design for pharmaceutical manufacturing plants.
Importance of Room Design in GMP Compliance
The design of a room is essential for ensuring product quality and preventing contamination. There are several hazards associated with improper design of facilities. Improperly designed facilities can result in:- Cross-contamination between products
- Mixing up materials or labels
- Microbial contamination
- Failing to meet the requirements of regulatory agencies
A facility that is correctly designed will provide a:
- Controlled environment
- Efficient flow of materials
- Reduced potential for human error
- Compliance with applicable regulations
As such, facility design is the first defense against quality assurance violations.
Key GMP Principles for Room Design
1. Segregation and Zoning
Pharmaceutical facilities have been divided into zones according to the processes that take place in them; this is sometimes referred to as their process zoning. The process zones are as follows:- Raw material storage
- Manufacturing
- Packaging
- Quality control laboratories
Proper zoning assists with the following:
- Preventing cross contamination
- Control of personnel and material transport
- Maintaining environmental conditions that are suitable for the activity being performed.
2. Logical Layout and Workflow
Logical layout and flow of materials and personnel through the GMP compliant facility should be in a single, directional pathway.This means:
- Raw materials are transported toward finished goods in one pathway
- Personnel use designated routes to enter and exit the facility
- There are no crossover pathways between clean and dirty areas.
3. Airflow and HVAC Systems
Air handling for rooms is very important for pharmaceutical room design.HVAC systems that are designed to do:
1. Maintain humidity and temperature
2. Control air particles
3. Prevent contamination
Some hallmarks of these systems include:
1. HEPA filter to remove particles and microorganisms
2. Using pressure differential to control the direction of airflow
3. How many air changes per hour are to be performed depending on the classification of the room
Some examples of how these hallmarks work are:
1. Areas of clean, higher pressure prevent contaminates from entering as the pressures in the area(s) is/are pushing out (therefore, transferring air out of the area); and
2. Areas with hazardous materials are kept at a lower pressure than areas without hazardous materials.
The air can be controlled through airflow control, which helps create a controlled, safe environment.
4. Cleanroom Design and Classification
Cleanrooms are defined as areas specifically constructed to be a controlled area of contamination, with classification determined via the number of particles.Features commonly associated with a cleanroom include:
1. Smooth, clean-able surfaces.
2. Sealed walls and ceiling
3. Minimum number of joints/corners
4. Access to and from the cleanroom limited to an airlock (i.e., control entry into or out of the cleanroom).
The classification of cleanrooms ensures that the cleanroom operates according to an established minimum standard, depending on the operation in the cleanroom.
5. Construction Materials
Construction materials used in pharmacy areas should be durable and maintain cleanliness.The types of acceptable construction materials include:
- Non-Shedding
- Smooth Surfaces to Aid in Cleaning
- Chemical & Disinfectant Resistant
- Durable / Long Lasting
Buildings constructed from poor material may lead to generation of particles and contribute to contamination.
6. Personnel and Materials Movement
To maintain GMP compliance there should be controlled movement of personnel and materials.Best Practices for Containment of GMP Compliance include:
- Separate Entry Points for Personnel and Materials
- Utilising Airlocks and Change Rooms
- Defined Pathways to Prevent Cross Contamination
7. Lighting and Visibility
Proper Lighting is essential for operational efficiency and Quality Control.Lighting Systems should be:
- Adequate Illumination
- No Shadows in Critical Areas
- Easy to Clean / Maintain Long Term
8. Utilities and Equipment Placement
The layout of utilities and equipment must promote efficient workflow and cleanliness. When planning the layout, the following design factors need to be considered:- Cleaning and maintenance ease of access
- No overcrowding
- Sufficient space between equipment items
Appropriate design of utilities (water, compressed air, gases) will reduce the potential risk of contamination.
9. Cleaning and Maintenance Design
Rooms must be designed to allow for ease of cleaning and for maintenance. The following features will support this requirement:- Rounded corners (curved)
- Flush-mounted fixtures
- Minimal edges and voids
The above design elements will aid in the reduction of the accumulation of dust and reduce the potential for the growth of microorganisms.
10. Environmental Monitoring Systems
Pharmaceutical rooms must contain and utilize systems for monitoring environmental conditions in these spaces.Parameters to be monitored include
- Temperature
- Humidity
- Particulate count
- Microbial contamination
This continuous monitoring will ensure environmental conditions remain within tolerances.
Role of Validation in Room Design
Room designs should be validated prior to their use.Validation consists of:
1. Installation Qualification (IQ)
2. Operational Qualification (OQ)
3. Performance Qualification (PQ)
Additional studies (for example, airflow visualization and recovery tests) are also performed. Validation provides assurance that the facility operates as designed in real-world use.
Future Trends in Pharmaceutical Facility Design
Pharmaceutical facility room designs are evolving with new technology.Some of the trends that are becoming more prevalent in facility room design include:
- Modular cleanrooms
- Automation/robotics
- Digital environmental monitoring systems
- Advanced contamination control methods
These new designs, systems and processes allow for greater efficiency, flexibility and compliance.
The essential element of the design of any pharmaceutical facility subject to Good Manufacturing Practices (GMP) is its physical layout. The physical layout of the facility has a direct effect on the quality of the products produced in that facility as well as on contamination control and compliance with regulations.
Pharmaceutical companies can improve the design of their facilities—thereby ensuring the safe and efficient operation of the business—by paying attention to zoning, air flow, materials and workflow.
A properly designed facility will allow for the meeting of regulatory requirements as well as an increase in productivity and consistency in producing high-quality medicines.
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ReplyDeletehello sir in cleaning validation is it required to take worst case product should be selected 2 product?
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