Ge-Shen Adds Liquid Silicon Rubber injection moulding process

With growing demand for liquid silicon rubber, especially in the medical, infant and baby care, electronics and industrial industry, Polyplas, a subsidiary of Ge-Shen has invested in Liquid Silicon Rubber (LSR) injection moulding capability and is ready to supply LSR products to its customers.

Why Liquid Silicon Rubber?

LSR injection molding provides consistent part quality and consistency as compared to other other elastomers and thermoplastics. It is able to achieve high precision, and if done well, is burr or flash free, direct from the mould.

Silicon rubber is tasteless and odorless, can be sterilized in a variety of methods and can be formulated to comply with FDA requirements. It is naturally resistant to bacteria growth, making it a perfect choice for medical devices and products.

It is durable, and can withstand extreme temperatures, fire resistant, water resistant and chemical resistant, making it very fit for industrial use. Its elongation, high tear and tensile strength, provides flexibility and durability and can be formulated to have hardness range of 5 to 80 Shore A.

 

Partners in mould making (or tooling)

While LSR is fairly new to us, we have various partners in the industry who has been producing LSR moulds (or tooling) for many years. The tooling they make can be of two types – open nozzles and shut-off nozzles. The choice of which to choose depends on the quality requirement and specific use. Our mould makers produces moulds which can guarantee burr or flash free finished products.

How we can help you

We are able to manufacture any of your LSR products. Whether it is to manufacture high volume and high mix of different parts, and from various industries. We are happy to receive orders for a variety of products including: bottle nipples, electronic products enclosure (for eg. external storage drive), seals and gaskets, valves, watch bands, medical face masks, Laryngeal masks etc.

With our partnership with various LSR mould makers, we will be able to assist you from tooling to mass production from our facility in Penang (including our clean room) within a short period of time and other facilities in Johor or Hanoi, on-demand.

 


Contact us now to know more about Liquid Silicon Rubber or tell us more about your mass production LSR requirement.

Medical Injection Moulding: 5 Things to Consider

Many injection moulding suppliers today have the ability to provide manufacturing services to the medical industry. But, is there more than just having injection moulding machines?

We have summarised 5 key things to consider when choosing a medical injection moulding supplier for your medical components and medical devices.

1. Environment

Depending on the product requirements, having suitable environment controls are important. Certain products are required to be manufactured in a clean room (like our Class-8 clean room), some in a controlled environment whilst others can be manufactured in any normal factory floor. It is essential to define this when searching for a medical injection moulding service service provider as cost and quality may vary.

Class 8 clean room provides dust free environment

2. Validation process

The IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification) process basically ensures that the the medical injection moulding process meets the quality acceptance criteria for the product. Whilst not all medical device requires this validation process, it is important to specify any requirement to the supplier up-front. This is to ensure that they understand the requirements of the validation process and provide adequate attention to this while developing the manufacturing process.

3. Certification of the medical injection moulding partner

When considering suppliers, have a look at their quality systems. the most basic ISO 9001 certification should be mandatory to ensure that the supplier has an adequate Quality Management System. Depending on your requirements, medical devices that require FDA approval or more stringent quality requirements, ensure that they have ISO 13485 and are up to date. Not all medical injection moulding requires ISO 13485, therefore be sure to tell your medical injection moulding partner the requirements up front.

4. Suite of capabilities

For most medical device manufacturers, it is important to ensure that their vendors are robust enough to have most processes in-house. This applies as well to the medical injection moulding vendor. While engineering skill-sets, like the ability to carryout design for manufacturability (DFM), mold / tool making and project management is important, also ensure that they have ability to do secondary processes. This includes having processes like liquid silicon rubber moulding (LSR), printing, ultrasonic welding and assembly. The less outsourcing, the better to ensure processes and quality is controlled.

5. Data

We cannot stress enough the importance to have data. Whilst traceability is part and parcel of ISO 13485, having a Manufacturing Execution System (MES) helps the capturing of data in a more autonomous manner. Having a stable Enterprise Resource Planning (ERP), Document Management System (DMS) and data security policy and procedures will greatly help ensure digital security, traceability and storage of documents. Hence, choose a vendor who is willing to invest in these systems to ensure that your supply chain management can be digitalize in the future.

Medical injection moulding with us:

  • Our plant in Penang, Malaysia is a certified ISO 13485 company and has a Class 8 clean room along with a control room. We have manufactured in this plant for the medical industry for over 10 years. We currently produce plastics for various medical equipment and single-use devices.
  • Our plant in Johor, Malaysia has manufactured plastic enclosures for medical equipment for over 5 years.

Contact us now to understand better how we can help you with your medical components.

Manufacturing in Malaysia

When someone says global manufacturing, most people would immediately think of China, maybe you might even think of Vietnam. Most people haven’t considered Malaysia as a manufacturing location despite how Malaysia is well positioned to take advantage of global supply chain. Let me give you 5 quick points on why you should consider manufacturing in Malaysia.

1. Malaysia has an established supply chain network

Malaysia has an established supply chain with global companies and strong local players. In fact companies such as Intel, opened their first manufacturing facilities in Malaysia in the 70s. The list has grown to include Robert Bosch, Clarion, Amphenol, B.Braun, Broadcom, Toshiba, Sony, Motorola, etc. The presence of these companies require material and resources which means the 2nd tier and 3rd tier vendors are well developed as a result this makes it easy to manufacture your product in Malaysia

2. LMW – Licensed Manufacturing Warehouse

We at Ge-Shen are a LMW – licenced manufacturing warehouse. This means that there are no tariffs placed on goods by the Malaysian government for goods related to manufacturing, in effect each of our factories are outside of Malaysia for custom purposes. Customs duty exemption is given to all raw materials and components used directly in the manufacturing process from the initial stage of manufacturing until the finished product is packed ready for export, easy!

3. Geography

Malaysia is well placed geographically. The straits of Malacca is one of the main global shipping routes. We are served by well established ports in Penang, Klang, Johor and we can even ship through Singapore. The proximity of Malaysia to China, Japan, South Korea and the rest of Asia also helps with sourcing and exporting finished goods.

4. English Speaking

Malaysia is a diverse country with many ethnic groups and languages, one of the upsides is that English is widely spoken as a business language. This means that we can communicate easily with you to get any issues resolved. Cutting out a layer of translation increases the ease of doing business.

5. Ease of doing business 

Malaysia ranks highly on the ease of doing business rankings as published by the World Bank http://www.doingbusiness.org/en/data/exploreeconomies/malaysia . Malaysia currently ranks at 15 across all economies in the world. Less red tape means it is easier to get things done, helping you with time to market.


Contact us to see how we can help you