Good practices in the use of a Clean Room for the injection of plastics and liquid silicone

The Clean Room is a controlled environment space where critical activities are carried out for quality, safety or performance of a product or process.

It is important to follow good practices in the design, use and maintenance of a cleanroom to ensure that the required standards are met. These include detailed procedures for cleaning, disinfection and monitoring of the environment, as well as training and education of personnel working in the room.

At OSF Plastic we have an ISO 7 Clean Room facility for manufacturing, handling and packaging processes to ensure a sterile product free of contaminating particles, thus meeting customer requirements.

Our customers for plastic and silicone injection in the Clean Room are in the medical and healthcare sectors, where it is vital that the Clean Room equipment and procedures are as strict as possible.

Design and equipment of a Clean Room

The design and construction of these spaces has specific requirements for environmental control, such as temperature, humidity, pressure, lighting and cleanliness and its objective is to minimize the generation and retention of particles inside the same at all times, so it is important to take into account the following aspects:

• Architecture: Enclosures, ceilings and floor coverings, as well as accessories such as doors, windows, light fixtures and closures, must be adequate to prevent contamination.
• Filtration: High efficiency air filters should be installed and used to remove particles and contaminants from the air; the particle retention efficiency of absolute filters, is key to determine air quality.
• Air conditioning: Air treatment should be adjusted to the room creating an air sweep for the purification of the area, in addition to temperature and humidity control.
• SAS (Sterile Access System): The areas of passage of materials and people to the clean room should be configured to reduce the risk of entry or exit of contaminants when accessing. Doors cannot be opened simultaneously, once one of them is open, the other is conditioned to the fulfillment of the pre-established cycle conditions.

We have worked with the company Humiclima  for the installation of the control equipment in the clean room. And with Tecnoprocesos  for the ISO 7 certification of our Clean Room, among other suppliers.

Clean Room processes

Processes in a Clean Room are strictly controlled to ensure the quality, safety and performance of the products or processes carried out in the Clean Room. Some of the common processes in a clean room include:

• Environmental control: The room environment, such as temperature, humidity, pressure, lighting and air velocity, is constantly monitored and controlled to ensure that it meets the required standards.
• Cleaning and disinfection: Daily and periodic cleaning and disinfection is performed to maintain a clean and contamination-free environment.
• Particulate Matter Monitoring: Airborne particulate matter is constantly monitored to ensure that it remains within established limits.
• Access control: Security measures are in place to control who enters and leaves the room and how material is handled and stored.
• Work procedures: Detailed procedures are established for the handling of materials and equipment, as well as for the education and training of personnel working in the room.
• Preventive maintenance: Regular preventive maintenance is carried out to ensure that equipment and systems are functioning properly and meeting required standards.
• Documentation: A detailed record is kept of all activities and processes carried out in the room, including environmental control, cleanliness, particle monitoring and work procedures.