Indonesia clean room installation
- Project name: Pharmaceutical Industry ISO6/ISO7 Clean Room Construction Project
- Customer information: Medium-sized Manufacturing Enterprise Pharmaceutical Industry in Indonesia
- Core Demand: Build a 600㎡ pharmaceutical-grade clean workshop with integrated labs, QA, and QC facilities. Ensure compliance with GMP/ISO standards, seamless integration with on-site construction, and support for production, customs clearance, and FDA certification.
- Project Level: Cleanliness Level (ISO6, ISO7) + Supporting Standards (ISO14644 Cleanliness Standard, pharmaceutical industry GMP compliance requirements, adapted to local Indonesian FDA relevant specifications)
- Delivery cycle: Launched in November 2022, successfully completed in early 2023, efficiently completing the whole process of design, construction and installation delivery
The clean room project sent by Suzhou Pharma to Indonesia has finished to be installed. The overall project is in 600 square meters, clean grade ISO6, ISO7 cleanliness, It is pharmaceutical machinery factory, the customer's factory mainly produces tablets, capsules, oral liquid and other medicines. The whole plant also includes laboratory, QA room, QC room.
When we discuss the design drawings, the customers factory building is under construction, so we need to check with the customers every angle of the construction details, to avoid construction changes caused by clean room design errors.
Project Key Challenge
The compliance inspection is strict, requiring compliance with ISO standards and local FDA specifications. At the same time, it is necessary to cooperate with product SGS and CCIC certification to ensure smooth customs clearance.
When the project was launched, the customer's factory was still under construction. The clean room design needed to be closely connected with the details of the factory construction. If the design was disconnected from the on-site construction, it would easily lead to construction changes, construction period delays and cost increases; the customer was not familiar with the clean room installation tools, accessory functions and installation processes, and needed professional guidance to ensure no construction deviations.
SZ-PHARMA Customized Solutions
Core Design Idea: Combined with the customer's production process of tablets, capsules and oral liquids, scientifically plan the layout of the clean area, reasonably separate the production area from the laboratory, QA room and QC room to realize the separation of personnel flow and material flow and avoid cross-contamination; synchronously connect with the customer's factory construction progress, communicate design details in phases, ensure seamless connection between clean room design and factory construction, and reduce construction changes.
Key Technology Implementation: According to the ISO6 and ISO7 cleanliness requirements, configure an efficient air purification system and select high-efficiency filters suitable for the pharmaceutical industry to ensure that the suspended particles, settling bacteria and other indicators in the clean area meet the standards; optimize the airtightness treatment of the clean room, focusing on solving the possible air leakage problems during factory construction; sort out the list of installation tools and accessories in advance, clarify the function, usage method and installation specifications of each accessory to avoid installation errors.
Compliance Adaptation: Strictly follow the ISO14644 cleanliness standard and pharmaceutical industry GMP compliance requirements, and conform to the relevant regulations of local Indonesian FDA certification in the whole process of design, construction and material selection; apply for SGS and CCIC certification for products in advance to assist customers in solving compliance problems during customs clearance and FDA certification application.
Meeting Core Indicators
- Cleanliness Indicators: The 600-square-meter clean area stably meets the ISO6 and ISO7 cleanliness requirements. The suspended particle detection values are ≤352000 particles/m³ (ISO7) and ≤3520 particles/m³ (ISO6), which are better than the ISO14644 standard.
- Supporting Indicators: The temperature and humidity fluctuation in the clean area is controlled within ±1℃/±5% RH, and the pressure difference is stable at 10-15Pa, meeting the strict requirements for environmental parameters during pharmaceutical production; the optimized purification system design reduces energy consumption by 8% compared with the industry average, reducing the customer's later operation costs.
Achieving Customer Demands
Compliance Aspect: The clean room construction fully complies with GMP specifications and ISO standards. The products have successfully passed SGS and CCIC certification, assisting the customer in completing customs clearance smoothly and laying a solid foundation for the subsequent local FDA certification application; the whole project has passed the customer's acceptance, meeting the requirements of the clean environment for pharmaceutical production.
Production Aspect: The synchronous delivery of the 600-square-meter clean production area and supporting laboratories, QA/QC rooms has been realized, which is perfectly connected with the customer's factory construction progress, with no construction changes or construction period delays, ensuring that the customer can start pharmaceutical production on time; the layout of the clean area is reasonable, with separate personnel flow and material flow, effectively avoiding cross-contamination and providing stable guarantee for product quality.
Review the process
Before delivery of the goods, we applied for SGS and CCIC certification for the products, which is more convenient for customers to clear customs and apply for local FDA.
The project start to built on November 2022.Before the start of the project, as usual, we introduced the installation tools required for the clean room to the customer, as well as the function and usage of each part of the accessories.
The customer carefully confirmed the installation process and required installation tools to us before the official start of construction,make sure there are no misunderstandings.By the beginning of 2023, the project was successfully completed and the customer was very satisfied.
Comprehensive and attentive service throughout the process, reducing customer collaboration costs: Before the project starts, we provide customers with a detailed explanation of the installation tools, accessories, and installation procedures for the clean room, assist them in confirming the construction details to avoid misunderstandings; we also handle the SGS and CCIC certifications of the products in advance, assist customers in solving customs clearance problems, and achieve "design + construction + certification + guidance" one-stop service, significantly reducing customer communication and collaboration costs.
If you have similar clean room construction needs or want to know more details about this project, please feel free to contact us via our official website: www.sz-pharma.com
