Some specific needs must be met when constructing a building for medical device manufacturing. That is to ensure the safety and efficacy of the products being made. This article will discuss some special requirements of a building for medical device manufacturing operations that should be considered during construction.
Air Quality Control
The air inside a medical device manufacturing facility must be kept clean and free of contaminants. This is typically accomplished using high-efficiency filters and an air exchange system.
A cleanroom is a type of controlled environment that is used in many medical device manufacturing operations. It is designed to minimize the introduction and spread of contaminants.
The air quality in a cleanroom is controlled by two main factors, particle size and air changes per hour. The maximum allowable particle size is typically specified by the cleanroom class. The number of air changes per hour is the other main factor determining the air quality in a cleanroom. Dust, airborne pathogens, or vaporized particulates are all prevented from contaminating this space through isolation and active cleaning procedures.
The international organization for standardization (ISO) has set several levels for grading cleanrooms’ cleanliness and air quality. The most delicate research and development operations, such as those involving semiconductors or biology, are the only ones that use the highest ISO 1 cleanroom grade. The minimum amount of sterility permissible is an ISO class 8 cleanroom. It is utilized when maintaining a minimal degree of cleanliness is more important than maintaining sterility. The storage of medications is one example.
An ISO 6 cleanroom is required for a medical device manufacturing facility. As a class 1000 cleanroom filtration system, it maintains maximum air purity values of 1,000 particles (0.5 m) per cubic meter of the interior air. It has air changes at a minimum of 180 per hour and a 20–30% filter coverage. An ISO 6 filtering system should have an airflow rate of 18–32 CFM for every square foot.
Temperature and Humidity Control
The manufacturing process for many medical devices is sensitive to changes in temperature and humidity. The facility must be designed to maintain consistent conditions within a specified range to ensure the proper equipment operation and the quality of the products being produced.
Controlling the temperature and humidity in a medical device manufacturing facility can be accomplished with various systems. The most common are HVAC (heating, ventilation, and air conditioning) systems with humidity control. HVAC systems work by circulating the air in the facility through a series of filters and cooled coils. The air is then passed over an evaporator coil to remove any moisture.
The temperature and humidity in a medical device manufacturing facility must be monitored regularly to ensure that they remain within the specified ranges. Logs should be kept of all readings to document the conditions in the facility.
It is also important to have a backup system in place in case the primary system fails. This can be accomplished with a generator or portable air conditioners and dehumidifiers.
Cleanliness
All surfaces within a medical device manufacturing facility must be kept clean and free of contaminants. This includes indoor air and all surfaces that come into contact with the product or packaging.
The maintenance of cleanliness in the facility must be ensured in its design and construction. The most common types of contamination found in a medical device manufacturing facility are dust and bacteria. Dust can be controlled through the use of air filtration and by regularly cleaning all surfaces. Bacteria can be controlled through disinfectants and by maintaining a clean environment.
Ceiling tiles, floors, walls, and other surfaces must be made of materials that can be easily cleaned and disinfected. The use of carpet is not recommended as it can be difficult to clean and may harbor bacteria.
All doors, windows, and other openings in the facility must be sealed to prevent contaminants from entering. All HVAC systems must be designed to provide the proper filtration to keep the air clean.
The water used in the facility must be of high quality and free of contaminants. This can be accomplished through the use of a water filtration system.
The waste generated in a medical device manufacturing facility must be properly disposed of to prevent contamination. This includes both solid and liquid waste. Solid waste must be placed in containers that are properly labeled and sealed. Liquid waste must be drained into a holding tank that is properly sized for the amount of waste generated.
Build a Safe and Compliant Medical Device Manufacturing Facility
These are just a few of the special requirements that must be considered when constructing a building for medical device manufacturing. By taking all of these factors into account, you can ensure that your facility is well-suited for the production of safe and effective medical devices.
