Clean Room Project From Russia
- Project name: ISO 8 Clean Room Construction Project in the Biomedical Industry
- Customer information: Medium-sized Manufacturing Enterprise of Biomedical Industry (Band-Aid Production) in Russia.
- Core Demand: Construct a 300㎡ special clean room for band-aid production, provide a complete set of electrical, water supply, ventilation and sewage systems, realize sterile prevention and control in the production area, and adapt to the actual conditions of the customer's factory building to ensure convenient installation.
- Project Level: Cleanliness Level (ISO 8) + Supporting Standards (relevant specifications for sterile production in the biomedical industry).
- Delivery cycle: 4 months (efficiently the whole process from demand docking, scheme design, production and processing to product delivery)
Our pharmaceutical modular clean-room mainly engaged in offering full service for system clean room engineering, including product manufacturing, equipment transport, construction control, engineering acceptance test, etc. We also could provide the service for design and personnel field survey, below are one case we have done for Russia customer.
Project Key Challenge
The customer lacks professional clean room design and construction capabilities, and it is difficult to find suitable processing tools and construction teams locally. If on-site processing and installation are carried out, it will not only delay the construction period but also significantly increase costs; moreover, due to the impact of the epidemic, Chinese technical personnel could not go to Russia for on-site installation, so it was necessary to solve the problem of convenient remote assembly.
The biomedical industry (band-aid production) has strict requirements on the sterile environment of the clean room, which needs to avoid cross-contamination between different clean areas, and at the same time, it must comply with the internationally accepted ISO 8 cleanliness standard to ensure product quality compliance.
SZ-PHARMA Customized Solutions
- Core Design Idea: Combine the customer's band-aid production process, optimize the clean room layout, clarify the division of production areas and material storage areas, reserve sufficient space for workers' activities around the machines, and also reserve enough space for storing packaging materials and semi-finished products; reasonably plan the flow of people, logistics routes, and design different pressures for every two adjacent rooms with an inner door to avoid pollution from rooms with lower cleanliness levels; simultaneously confirm the water layout, gas layout, circuit layout and workflow layout, as well as the new functional rooms and their sizes. During the quotation period, it is very important for both us and the customer to confirm the layout. Once confirmed, it is better not to change it, because even a small difference will cause many problems for the entire system. Finally, we finalized a detailed design with sufficient details.
- Key Technology Implementation: Adopt modular clean room design, all panels and components are pre-processed to appropriate sizes in our factory to avoid on-site cutting and processing; split large components into small pieces for easy transportation by containers, and mark each component with sequential numbers so that the customer can know how to assemble them, avoiding damage and loss of parts; configure a ventilation system that meets ISO 8 standards, accurately control the indoor temperature at 22-25℃, and install UV lamps in the production area for sterilization; provide a complete set of electrical parts, water supply system, ventilation system and waste routes as required by the customer.
- Compliance Adaptation: Strictly design in accordance with the ISO 8 clean room standard, focus on key links such as pressure difference control between adjacent rooms, sterile sterilization and pollutant prevention and control, meet the sterile requirements for band-aid production in the biomedical industry, and ensure that the project complies with international general specifications to guarantee the compliance of product production.
Meeting Core Indicators
The indoor temperature is stably controlled at 22-25℃ without obvious fluctuations; the pressure difference between adjacent rooms is reasonably controlled, effectively preventing pollution from areas with lower cleanliness levels to those with higher cleanliness levels; the sterilization effect of UV lamps meets the standard, satisfying the sterile requirements of the production area; all components have strong adaptability, are easy to assemble, and do not require additional processing.
Compliance Aspect: The project design and delivery fully comply with the ISO 8 standard and biomedical industry specifications. After receiving the products, the customer can directly assemble and put them into use without additional rectification to meet the production compliance requirements.
Production Aspect: Successfully delivered a 300㎡ clean room that meets the requirements, reserved sufficient operation and storage space to ensure the smooth progress of band-aid production; the modular pre-processing + numbered assembly design solved the problem of remote installation, avoiding the construction period delay and cost increase caused by on-site processing.
What can we do?
Adopt the "factory prefabrication + modular splitting + numbered assembly" mode, which completely solved the problem that Chinese technical personnel could not go to Russia for installation during the epidemic and the lack of processing tools locally, realizing convenient remote assembly, while shortening the construction period and reducing the customer's additional costs.
Provide one-stop full-process delivery services, including demand docking, on-site survey, scheme design, product production, transportation, remote guidance for assembly, etc. Send the layout drawings to the customer for confirmation many times in advance to avoid errors found after construction. Each part is marked with a special number consistent with the actual product, so that the customer can find the parts according to our drawings and learn the installation sequence.
Send multiple layout drawings to the customer for confirmation before shipment to ensure that the design and layout meet the customer's requirements, avoiding errors found after construction. Each part is marked with a special number consistent with the design drawings, facilitating the customer to check and install.
Provide comprehensive technical support, remotely guide the customer in component assembly, answer various questions during the installation process, and ensure that the customer successfully completes the clean room construction.
