The Regular Customer Expansion Of The Clean Room On 2022

• Project name: ISO7 Clean Room Expansion Project in the Medical Device Industry
• Customer information: Medium-sized manufacturing enterprise of medical device industry in India
• Core Demand: Cleanroom expansion, construction of a hard-wall clean room complying with ISO standards, adapted to the production needs of syringe assembly and injection products, and guaranteed production efficiency and clean environment.
• Project Level: Cleanliness class ISO7 + supporting standard ISO14644 General Specifications for Clean Rooms.
• Delivery cycle: 5 working days (clean room delivery) + simple and fast installation (supported by prefabricated design and supporting materials).

Since the customer's first project in 2019, the customer's project expansion will be ushered on March 2022, and the customer has purchased a clean room again. It is a hard wall (anti-glass)clean booth also used for Syringe assembly machine and Injection Products.

Project Key Challenge

·  Industry Common Pain Point: Clean rooms need to be adapted to the layout of production equipment, and the delivery and installation cycle must align with the production capacity expansion rhythm to avoid affecting capacity improvement.

·  Personalized Pain Point: The area of the original production clean room is insufficient to meet the demand for production capacity expansion. Additional clean space is required with the requirement of convenient installation, without occupying excessive production preparation time.

SZ-PHARMA Customized Solutions

1. Core Design Concept: Combined with the customer's production process of syringe assembly machines and injection products, a 50 square meter modular clean room design is adopted. The clean room can be used independently or combined with the existing factory walls and ceilings, perfectly adapting to the customer's existing production layout without the need for large-scale transformation of the original production area.

2. Key Technology Implementation: A hard-wall (anti-glass) clean booth structure is selected to ensure the sealing and structural stability of the clean room; a factory full prefabrication production mode is adopted, with all components finished in the factory, minimizing on-site installation procedures. At the same time, clean room accessories are stocked in bulk to ensure the continuity of delivery and use.

3. Compliance Adaptation: The design and construction are strictly in accordance with the ISO14644 General Specifications for Clean Rooms, with the cleanliness level reaching ISO7, which fully meets the clean environment requirements for the production of syringes and injection products in the medical device industry.

Meeting Core Indicators

·  Cleanliness Indicators: Stably meeting the ISO7 cleanliness standard, with the test values of key indicators such as airborne particles and settling bacteria all superior to the requirements of the ISO14644 industry specification.

·  Supporting Indicators: The modular structure achieves stable and controllable pressure difference inside the clean room, adapting to the environmental requirements of production equipment operation; the prefabricated components ensure the standard overall sealing performance of the clean room without air leakage, cleanliness leakage and other problems.

Achieving Customer Demands

•  Compliance Aspect: The clean room has successfully passed the customer's internal acceptance, and all design and construction standards are in line with the ISO14644 specifications and the compliance requirements of the customer's production site.
• Production Aspect: The 50 square meter clean area expansion has been successfully realized, perfectly adapted to the production of syringe assembly machines and injection products, helping the customer improve production capacity; relying on factory prefabrication and simple installation processes, the clean room implementation has no impact on the customer's existing production, achieving a seamless connection between capacity expansion and production.

Totally 50 square meters working areas and clean grade ISO7 modular clean room design allows it to be used as either a totally freestanding room or it can be used in combination with the existing walls and ceiling. Each room comes completely factory prefabricated for minimal on-site erection time and is totally self-contained with all components factory-finished.

To increase production speed, we stock cleanroom accessories in bulk. So far, this kind of cleanroom lead time about 5 working days. In order to simplify the installation process, we have prepared complete installation drawings and installation videos for customers, which are easy to understand. 

Suzhou Pharma Machinery Co.,Ltd.

2022/06/28

Lucy