Clean room and silicone parts production: What products are really needed, and what are not

We have a dust-free workshop "is a selling point promoted by many silicone factories. However, the cost and operating cost of cleanrooms vary greatly depending on their level and purpose. For the lower party, it is important to clarify whether their product requires clean production and what level is required in order to avoid paying for items that are not needed or placing orders in factories that do not have the necessary conditions.

What is a clean room

A clean room is a production environment that controls the concentration of suspended particulate matter in the air to a certain level, while also controlling temperature and humidity. The commonly used domestic standards refer to GB 50073 (corresponding to ISO 14644), and the grade is represented by numbers: the smaller the number, the cleaner it is.

ISO Level 8 (100000 level) - General cleanliness requirements, starting level for environmental control. ISO Level 7 (Class 10000) - Medical consumables, some electronic components. ISO Level 6 (Class 1000) - High demand medical devices, precision optics. ISO Level 5 (Class 100) - related to sterile medical devices and implants.

For silicone parts, the mainstream demand is concentrated in ISO 7-8 levels.

What silicone products really need clean production

Medical consumables - catheters, seals, valve accessories that come into contact with the human body, require controlled production environments according to regulations and registration reviews. This is not a question of 'whether or not', it is a threshold for entry.

Silicone components in consumer electronics such as mobile phones, headphones, and watches must undergo cleanliness inspection (particle residue, ion contamination) before entering the customer assembly workshop, otherwise they will be claimed for contaminating the customer's production line. Headphone plugs, sealing rings, and other components are produced in environments designated by many brands as Class 10000 or above.

Optical related products - sealing and buffering components for camera modules. A single speck of dust on silicone components is considered a defective product, and these types of products are subject to strict environmental and factory inspections.

Food contact category - strictly speaking, food grade silicone does not require a cleanroom, but mainstream brands generally require a cleanroom and clean packaging because the risk of foreign matter contamination is unacceptable.

Unnecessary situations

The vast majority of industrial components: automotive shock absorbers, household appliance seals, ordinary buttons, silicone floor mats - these products are not sensitive to particulate matter and are adequately managed in ordinary workshops and on-site. Paying for the cost of clean workshops for these products is purely wasteful.

How to verify the next party

Don't look at the photos, look at the scene. The photo of the dust-free workshop on the brochure may be the only one, and daily production may take place in the adjacent regular workshop. When inspecting the factory, you can directly see which workshop your product is produced in.

Check the monitoring records. The clean room should have regular records of dust particle detection and settling bacteria detection. Regular operating laboratories should have a ledger, and "clean rooms" that cannot provide records should be marked with a question mark.

Verify by region. A factory that truly designs according to specifications will be divided into sections based on the process route: raw material room, molding room, and inspection packaging room with different levels. It is often untrue to label a large communication room in the entire factory as "ten thousand level".

Clean packaging is a complementary action. The workshop is clean, but packaging in ordinary areas is done in vain. High demand orders require confirmation that the packaging process is completed in a controlled environment, and the packaging materials themselves (clean bags, double-layer packaging) must also be confirmed.

Cost accounting from a factory perspective

Build an ISO 7 molding and packaging area, including air shower FFU、 The air conditioning system, regular inspections, and product discounts are a real cost markup. Take the order for medical electronics, this investment is for admission tickets; Only producing industrial components, this investment is a burden. So when placing an inquiry, the ordering party should clearly state the cleanliness requirements of the product - for products that require clean production, a high quotation is reasonable; Don't pay a premium for selling points if you don't need it.

A clean workshop is not mysterious, it is just a controlled environment with a continuous monitoring record. It depends entirely on whether your product is worth it or not.