In pharmaceutical manufacturing, the design of sterile facility plays a pivotal role in ensuring product safety and compliance with regulatory standards. Sterile facilities are environments where sterile drug products are produced, packaged, and tested, requiring strict control over cleanliness and the prevention of contamination. A well-thought-out design not only improves efficiency but also minimizes maintenance costs and upholds the sterile environment’s integrity. Below is a breakdown of critical design elements for sterile facilities in pharmaceuticals.
Considerations in Design of sterile facility
1. Walls: Smooth and Non-Shedding Surfaces
The walls of a sterile facility must be designed with materials that minimize particle generation and microbial contamination. Smooth surfaces are crucial to prevent the shedding of particles, which can compromise the sterile environment. Materials like steel or epoxy-coated panels are ideal because they are durable, easy to clean, and resistant to microbial growth.
Additionally, the design should eliminate sharp edges or areas where particles can accumulate. Curved corners between walls and floors, known as coving, are often implemented to prevent dust accumulation, making it easier to clean and maintain sterile conditions.
2. Floors: Durable, Non-Porous, and Easy to Clean
The flooring in sterile pharmaceutical environments must be non-porous, non-slippery, and easy to clean. The material should be resistant to disinfectants used in regular cleaning procedures. Generally, a 3.5 mm thick epoxy coating is used on floors in pharmaceutical clean rooms. This epoxy layer provides durability, resistance to chemical wear, and ensures that no pores are present to harbor contaminants.
Additionally, coving should be used at the edges where the walls meet the floor. This design prevents the accumulation of dust or debris, facilitating efficient cleaning and reducing the risk of microbial contamination.
3. Ceilings: False Ceilings to Minimize Contamination
The ceiling design in a sterile facility is just as critical as the walls and floors. False ceilings are commonly employed to conceal utility pipes, air ducts, and electrical wiring, which can act as potential sources of contamination. However, the false ceiling must be sealed properly to prevent particles from seeping into the sterile environment.
Gaps or cracks in the ceiling can compromise the sterile conditions by allowing contaminants to enter. Therefore, careful attention must be given to ensure that the ceiling is crack-free and the joints between panels are sealed to maintain a contaminant-free environment.
4. Doors: Pressure-Controlled and Self-Closing
Doors in a sterile facility must be easy to clean and designed to maintain the pressure differential between rooms. This is crucial because contamination risks are higher when air flows from a less sterile area to a more sterile one. To counteract this, doors should open to higher pressure areas, effectively preventing contaminants from entering.
In addition, doors should be equipped with automatic self-closing systems to minimize the risk of manual handling errors. Sliding doors, which might seem space-efficient, are generally avoided because they can accumulate dust and particles in their tracks, making them harder to clean and maintain.
5. Drains: Controlled to Avoid Contamination
The design of drainage systems in sterile facilities must also be carefully managed to prevent contamination risks. In Class A and Class B areas, where the highest levels of sterility are required, drains or sinks are usually prohibited. This is because such features can introduce microbial contamination through water stagnation or backflow.
However, if a drain or sink is necessary in these areas, it must be easily cleanable and designed to ensure that it drains completely, preventing standing water. Moreover, drains should lead outside the sterile environment to avoid contamination risks.
6. Lighting: Adequate and Non-Contaminating
Adequate lighting is essential for workers to perform tasks accurately in sterile environments. The light intensity should range between 600-1000 LUX, and the lighting system must provide uniform illumination without causing shadows or glare. Comfortable light colors are preferred, as they reduce eye strain for personnel working in the area for extended periods.
In addition, light panels must be properly sealed to prevent contaminants from entering the clean room through gaps around the lighting fixtures. Ensuring the cleanliness of light fixtures is crucial, as dust can accumulate on exposed panels and spread through the air during operations.
Efficiency and Maintenance in Sterile Facility Design
The overall design of a sterile facility not only focuses on creating a contamination-free environment but also on efficiency and ease of maintenance. A well-designed facility will minimize operational costs, streamline cleaning procedures, and improve the safety and efficacy of the sterile environment.
Conclusion
The design of a sterile facility in pharmaceuticals is a delicate balance between functionality, cleanliness, and cost-efficiency. From wall materials to door types, each element plays a critical role in maintaining the integrity of the sterile environment. A well-designed sterile facility not only ensures the safety of pharmaceutical products but also optimizes maintenance and operational efficiency, resulting in better compliance with regulatory standards and reduced risk of contamination. With proper planning and design, pharmaceutical companies can maintain high-quality sterile conditions while reducing costs and improving productivity.
FREQUENTLY ASKED QUESTIONS :
What is sterile area in the pharmaceutical industry?
A sterile area is a controlled space where the risk of contamination from microorganisms is minimized through air filtration, pressure controls, and personnel protocols. These areas are used for manufacturing products that require sterility, like injectables.
What is the best method of sterile?
Aseptic processing and terminal sterilization are considered the best methods depending on the product. Aseptic processing is used when the product cannot withstand terminal sterilization conditions, while terminal sterilization is ideal for heat-stable products.
What are 5 aseptic techniques?
The five aseptic techniques are:
- Hand hygiene: Cleaning hands before handling sterile products.
- Gowning: Wearing sterile clothing.
- Disinfection: Using sterilizing agents on surfaces and equipment.
- Laminar flow hoods: Using airflow systems to maintain sterility.
- Proper handling of sterile products: Avoiding contact with non-sterile items.
What is a sterile room called?
A sterile room is typically referred to as a clean room or a controlled environment room. Clean rooms are specifically designed to control airborne contamination through the use of air filtration systems and strict gowning protocols.
What is the difference between sterile and aseptic?
Sterile refers to the complete absence of all microorganisms, while aseptic refers to the methods used to prevent contamination by microorganisms. Sterile conditions are the goal, while aseptic techniques are the means to achieve it.
What is the ISO standard for sterilization?
The ISO standard for sterilization is ISO 13408, which covers aseptic processing of health care products, including sterilization techniques to ensure that products meet sterile requirements.
Who CSSD guidelines?
The CSSD (Central Sterile Supply Department) guidelines are published by organizations like the World Health Organization (WHO) and local regulatory bodies, outlining best practices for sterilizing and preparing medical equipment for use.
What is the temperature for sterilization?
Sterilization typically occurs at a temperature of 121°C (250°F) for steam sterilization (autoclaving), although other methods, like dry heat sterilization, may use temperatures of 160°C to 180°C.
What is the ACH in CSSD?
ACH (Air Changes per Hour) in the CSSD ensures that the air is replaced frequently enough to maintain a clean environment. The recommended ACH for a sterile area is typically 20-25 air changes per hour.
What is the room temperature for sterile supply?
The room temperature for sterile supply is usually maintained between 20°C and 24°C to ensure that the environment is comfortable for personnel while maintaining the integrity of sterile products.
What is a sterile facility?
A sterile facility is a specialized pharmaceutical or medical manufacturing plant designed to produce products in a controlled, contamination-free environment. These facilities incorporate clean rooms, sterilization equipment, and strict environmental controls.
What are the 7 principles of sterility?
The seven principles of sterility are:
- Sterile to sterile contact only.
- Keep unsterile items away.
- Keep sterile items within the sterile field.
- Keep your hands in sight.
- Discard any items that are contaminated.
- Maintain sterile boundaries.
- Use only sterile tools.
What are the 4 principles of sterility?
The four core principles of sterility are:
- Maintain a sterile field.
- Prevent contamination.
- Use sterile instruments.
- Discard anything suspected of being contaminated.
How to maintain sterility?
Sterility is maintained by using aseptic techniques, adhering to proper gowning procedures, disinfecting surfaces, and ensuring that all tools and materials are properly sterilized before use.
What does ANTT stand for?
ANTT stands for Aseptic Non-Touch Technique, a method of maintaining asepsis by ensuring that sterile objects are not touched by unsterile items or hands.
What are the 2 types of aseptic?
The two types of aseptic methods are:
- Aseptic preparation: Methods used to keep an environment sterile.
- Aseptic transfer: The transfer of sterile products in a manner that maintains sterility.
What are the rules for sterile field?
The main rules for a sterile field include:
- Only sterile items can enter the sterile field.
- Sterile barriers must be maintained.
- Contaminated items must be discarded immediately.
- Avoid excessive movement around the sterile field.
What is SOP in CSSD?
An SOP (Standard Operating Procedure) in the CSSD outlines the specific processes and steps required for the sterilization, preparation, and handling of sterile supplies and equipment.
What is CSSD layout?
The CSSD layout typically includes separate areas for decontamination, packaging, sterilization, and storage. This layout ensures a unidirectional flow to prevent cross-contamination.
What PPE is used in CSSD?
Personnel in the CSSD must wear personal protective equipment (PPE) such as sterile gowns, gloves, masks, hairnets, and shoe covers to prevent contamination of sterile supplies and the working environment.