Ge-Shen, a B2B leader in design, development and technology-driven manufacturing products for clients globally, has successfully obtained certification for a new 4,863 sq. ft. 100K cleanroom facility. The first certified ISO Class-8 (FED STD 209E – 100K) cleanroom in Penang was built in 2019 and this facility is 3 times bigger, with 18 injection moulding machines, ranging from 60 tonnes to 200 tonnes within it.
This cleanroom is destined to cater to its growing client base, especially in the US and Europe region but also locally in Johor and entire Malaysia. This 100K cleanroom injection moulding facility in Johor will boost Ge-Shen’s ability to serve medical customers better.
National Environmental Balancing Bureau (NEBB) cleanroom certified to 100K (100,000 particle count and below) based on ISO14644:2015 standards, the cleanroom has airflow of 20 cycles per hour. Temperature is controlled at 25c +/- 1c with a relative humidity of 60% +/- 5%. The room is designed with minimum dead corners, external material feeding and vacuum-operated feed system, to minimize material movement.
Individuals are required to wear protective clothing like hairnets, face masks, gloves, smock and shoe cover to maintain the highest safety and quality standards at all times. With good design and equipment that controls temperature and humidity fitted with HEPA filters that eliminates airborne particles, Ge-Shen is able to produce high quality parts in a dust free environment, twenty-four hours a day, seven days a week.
The investment in the cleanroom follows the successful ISO13485 certification in July 2020, and is a testimony of Ge-Shen’s commitment to continuously improve itself.
“The successful certification of the 100K Cleanroom is the start of a very exciting journey. We are also currently training to be certified in ISO22000 for Food Safety Management, Good Manufacturing Practice (GMP), and Hazard Analysis Critical Control Point (HACCP) – and aiming to complete training by the end of June 2021.
“Increased demand and enquires for medical injection, moulding, and facilities capable to handle food related products led to the decision to invest in this upgrade and expand our operations nearly 6 months ago. Today it has become reality. All thanks to the dedicated teams at Ge-Shen for working tirelessly and ensuring zero disruptions on day-to-day operations, while also overseeing the design and implementation of the renovations.
“We are still hungry for growth. Since the start of the pandemic, we have increased our machine capacity by more than 20% in our Johor plant alone. With the additional injection moulding machines in our Johor plant, we are looking to better meet the needs of current strategic partners and grow new partnerships with customers across the US, especially in the medical, life sciences, food, home and lifestyle product sectors.”Louis Lau, Executive Director of Ge-Shen Corporation Berhad
Apart from a Cleanroom, Ge-Shen has also renovated its facility to include a 13,535sqft control room. This control room has also the ability provide clean and dust-free environment, suitable for food-related, household and medical products.
Founded in 1995, Ge-Shen celebrates its 25th year as a precision injection moulding contract manufacturer this year. Ge-Shen has great experience in high-precision, injection moulding for audio products with great emphasis on aesthetics. In recent years, the company started diversifying into different industries with a focus on the medical, life sciences, food, home and lifestyle product sectors. To meet client demand, Ge-Shen has made large investments in upgrading its facilities. Ge-Shen has ISO 9001 and ISO 13485 certified locations across Malaysia and Vietnam. The company specializes in top-of-the-line products at competitive prices.
For more information, please contact Louis Lau, Executive Director of Ge-Shen Corporation at firstname.lastname@example.org