Non-Dust Room Molding

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non-dust room molding for FDA-grade LSR injection

What Is a Non-Dust Room Molding?

Non-dust room molding, or clean room molding, refers to the process of manufacturing products in a controlled environment known as a clean room. A non-dust room is a specially designed space with a controlled level of airborne particles, temperature, humidity, and other environmental conditions. The primary purpose of clean room molding is to minimize the risk of contamination during the manufacturing process, particularly in industries where product purity and quality are critical, such as pharmaceuticals, medical devices, electronics, and aerospace.

Non-dust room molding is crucial for producing sensitive items like medical devices and electronic components. This process occurs in a controlled environment with minimized airborne particles, maintaining stringent temperature, humidity, and cleanliness standards. In industries where product quality and safety are paramount, such as healthcare and electronics, clean room molding ensures precision and minimizes the risk of contamination, guaranteeing the highest standards of excellence in the final products.

Key Features of A Non-Dust Room

LSR overmolding is a process that entails covering, bonding, or encapsulating a substrate or finished component with liquid silicone rubber (LSR) during the molding process. Here's how the LSR overmolding process unfolds:

Controlled Atmosphere

The environment within a non-dust room is carefully regulated to maintain specific levels of cleanliness and sterility.

Airborne Contaminant Reduction

Special filters and airflow techniques are employed to reduce the presence of dirt and various airborne particles within the non-dust room.

Preventing Contamination

The design of a non-dust room is structured to prevent airborne particles from coming into contact with sensitive components, ensuring the manufacturing process remains as hygienic as possible. Overall, the goal of a non-dust room is to provide one of the cleanest and most controlled environments possible, essential for the production of critical and sensitive products across various industries.

Precision in Hygiene: LSR Non-dust Room Molding Liquid Silicone Rubber (LSR) possesses inert properties, making it hypoallergenic and biocompatible, with resistance to various substances. Widely utilized in surgical and medical devices, biotech and diagnostic products, wearable healthcare devices, baby products, and micro-electronics, LSR meets diverse hygienic requirements. The specific hygienic standards vary based on end-use, ranging from specialty medical and FDA-approved grade LSRs to stringent cleanliness mandates necessitating production in a controlled environment.

Potential contamination risks arise at multiple stages of the molding process, potentially affecting LSR parts. Workers involved in machine setups and mold changeovers may introduce oils or contaminants, while dust, grease, and airborne particles pose additional threats. Isolating and maintaining injection-molded silicone parts within a controlled clean environment mitigates the risk of contamination, enhancing traceability and ensuring product integrity.

medical liquid silicone rubber injection mold process for mask cover

ISO Standards for Non-dust Room

The International Organization for Standardization (ISO) plays a crucial role in establishing certification requirements, particularly through ISO Standard 14644. This standard outlines the classification of air cleanliness within hygienic environments, specifically focusing on the concentration of airborne particles. Initially introduced in the early 2000s and revised in 2015 to incorporate technological advancements and evolving market needs, ISO 14644-1 provides a classification system for non-dust rooms.

Non-dust rooms are categorized from ISO Class 1 to ISO Class 9, with the latter imposing the most stringent requirements. These classifications are determined based on the allowable amount and size of particles per volume of air within the room. The size and concentration of airborne particles in a clean room can vary from 0.1 to 5 microns, dictated by the room's specific classification. Adhering to ISO standards ensures a standardized and regulated approach to maintaining hygienic environments.

Applications of LSR Non-dust Room Parts Production

The inert and biocompatible nature of Liquid Silicone Rubber (LSR) positions it as an ideal material for medical devices and products in direct contact with bodily fluids or the human body. To meet stringent hygiene standards, these parts often necessitate production within a non-dust room environment. Various devices and products that demand hygienic production conditions include:

1. Surgical instruments and devices

2. Pharmaceutical products

3. Biotechnology products

4. Parts and products used for diagnostics

5. Medical devices in direct contact with the body

6. Fluid management and drug delivery devices

7. Respiratory products

8. Nanotechnology and microelectronic components

LSR Non-dust Room parts production ensures the integrity and safety of these critical applications, aligning with the stringent standards required in the medical and healthcare industries.

ISO Class 8 Clean Room Features

An ISO Class 8 clean room permits particles from 0.5 to 5 microns, with specific limits for various sizes. It accommodates a maximum of 3,520,000 particles larger than 0.5 microns, fewer than 832,000 particles exceeding 1 micron, and up to 29,300 particles larger than 5 microns.

Critical to the classification is the requirement for 10 to 25 air changes per hour, measured by the volume of air passing through a HEPA filter divided by the room’s volume.

Design features include:

1. Air Systems: Employing airlock or positive pressure airflow systems to prevent outside air infiltration.

2. Flat Walls and Floors: Whether soft-paneled or hard-sided, flat surfaces minimize particle accumulation and ease cleaning.

3. Entry Protocols: Enforcing strict protocols for individuals entering, including dress codes, to minimize contaminants. These features collectively establish a controlled and hygienic environment crucial for precision molding and other procedures in an ISO Class 8 clean room.

How it Works

ISO Class 8 clean room is tailored for high-volume medical devices, offering a certified, hygienic production environment. The process includes:

1. Equipment Placement: Molding machines and ancillary equipment are outside the clean room.

2. Contamination Mitigation: Tooling changes and related activities occur outside, reducing contamination risk.

3. Automated Handling: LSR molded parts are robotically moved into the clean room in a controlled enclosure.

4. Zero Human Touch: Parts remain untouched, ensuring no exposure to external contaminants.

5. Inline Processes: Automated steps post-molding are performed in a controlled environment before transfer to the clean room for inspection and packing.

6. Non-Clean Room Option: For customers not needing a clean room, SIMTEC’s automated cells ensure precision and high-output production with minimal human contact.

Our ISO Class 8 clean room boasts a hybrid and modular design, combining versatility with rapid expansion capabilities. This innovative approach features a unique layout and material flow, providing the benefits of a standard clean room while minimizing limitations. This design ensures efficiency, adaptability, and easy scalability for your evolving production needs.

Contact Jiaze Silicone to explore how our ISO Class 8 clean room can meet your hygienic molding requirements.