What are sterility areas or areas of sterile conditions in laboratories?

Sterility areas or sterile conditions areas in laboratories are controlled environments designed to prevent microbiological contamination during the handling and production of pharmaceuticals, biologicals, medical devices and other materials that must be kept sterile.

These areas are critical to ensuring the safety and effectiveness of products that will be administered to patients, especially those that are injected directly into the body, applied to open wounds, or used in surgical procedures. Key aspects of sterility areas are described in detail below. They are also essential to prevent contamination of products that, if contaminated, can cause serious infections or endanger the lives of patients.

Sterility is particularly important in the production of injectable medications, intravenous solutions, ophthalmic products, implantable devices, and other critical use products. Contamination in these products can result in therapeutic failures, nosocomial infections and other health risks.

How sterility areas are classified

The design of sterile areas follows strict regulations established by regulatory entities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

These regulations include guides such as Good Manufacturing Practice (GMP) that dictate standards for the manufacturing of pharmaceutical products and medical devices.

  • Class A (Grade A): Also known as the laminar flow area, it is the most critical area where the most sensitive operations are performed, such as filling and capping vials. These areas must maintain extremely low levels of particles and microorganisms.
  • Class B (grade B): This area surrounds the class A zones and is used for support activities. Cleanliness and air quality are very high to avoid cross contamination.
  • Classes C and D (Grades C and D): These areas have progressively lower levels of cleanliness and are used for the less critical stages of production. Still, high cleaning standards are maintained to minimize contamination.

Air control

Sterile areas use advanced heating, ventilation and air conditioning (HVAC) systems with HEPA (high-efficiency particulate air) filters to maintain air quality. These systems ensure laminar air flow that minimizes turbulence and particle accumulation.

Physical barriers

Physical barriers such as laminar flow cabinets, isolators, and containment barriers are used to separate critical production areas from less controlled areas.

Operating procedures in sterile areas

Maintaining sterile conditions requires strict and well-documented operating procedures. These include sterilization of equipment and materials, where all equipment and materials entering sterile areas must be sterilized using methods such as autoclaving, irradiation, sterile filtration, or ethylene oxide gas.

Personnel control is also important. Employees working in sterile areas must wear sterile protective clothing, including gowns, gloves, masks and caps, and must follow strict hand and face washing and disinfection procedures before entering.

On the other hand, environmental monitoring is carried out through regular environmental controls to monitor the presence of particles and microorganisms in the air and on surfaces, including the use of contact plates, air sampling and sediment analysis.

And cleaning and disinfection of sterile areas is carried out regularly using approved agents that do not leave toxic residues, following an established and documented schedule, and any contamination incidents must be recorded and analyzed.

Sterility areas are essential in laboratory facilities to ensure the safe and effective production of pharmaceuticals and medical devices. These areas are designed and maintained under strict regulatory standards to prevent microbiological contamination, thus protecting the health of patients.

Contact our team of experts if you need more information on sterility analysis of medicines and medical devices, as well as additional data on processes in our sterility areas.