Liquid Silicone Rubber (LSR) parts and components are particularly well-suited for medical devices, mother and child care products, sanitary products, and others products with hygienic requirements. LSR is inert, resistant to many substances, and because it’s bio-compatible it works well for products with skin contact. LSR parts that are used in medical devices additionally require that production is in a hygienic controlled environment, and many may also require sterilization.
LIMITING CONTAMINANTS DURING MANUFACTURING
When manufacturing parts for medical devices, the surrounding environment plays a large role in assuring the cleanliness of the LSR component. When molding LSR parts with hygienic requirements, contaminants such as dust and other airborne particles are controlled and minimized using advanced filters, air-flow and other procedures to prevent contact with the parts during the production process. In a standard production environment, these particles cannot be excluded effectively enough to prevent contact with the parts.
LSR and LSR Multi-Shot components can become contaminated during the molding process in the following ways:
- Particles from material staging
- Particles from an operator
- Dust or other contaminants accumulate on equipment or are carried in during set-up
- Air outside the controlled environment enters the production area, affecting the material and/or parts
Usually, a clean, standard molding operation has little risk in terms of the cleanliness on the LSR parts. However, manufacturers in some industries, including the medical and life sciences, need parts that have been manufactured in a controlled environment. In this case, LSR molding needs to take place in a certified clean room.
DESIGNING A CLEAN ROOM
The International Organization for Standardization (ISO) has established standards for clean room design and classification. ISO clean rooms are defined by the number of particles present in the air. The ISO standards require clean rooms under this classification to circulate and filter the air continuously, resulting in a certain number of air changes per hour.
A room is considered Class 8 when its particle concentration is below the designated standard for particles sized 0.5, 1, and 5 microns.
To ensure proper hygiene in the manufacturing area, a Class 8 clean room needs:
- An airlock or another system for keeping outside air out
- An effective air filtration and circulation system
- Perfectly flat walls and floors to deter dust accumulation and for ease of cleaning
- Operators who are properly dressed and follow specific procedures to keep the room clean
INTRODUCING OUR CLASS 8 CLEAN ROOM
Medical device, life science, and sanitary product manufacturers have high expectations for their components. Our exceptionally clean manufacturing facility, along with our highly automated molding and packing process reduces human contact and contaminants. To further meet our customers’ stringent hygienic requirements, SIMTEC Silicone Parts now offers certified class 8 clean room LSR molding. LSR parts produced in this room are ideal for companies manufacturing medical devices and other products where hygiene is critical.
If you have hygienic product requirements, contact a SIMTEC representative today to discuss your specific project requirements.