Cleanroom Built in Saudi Arabia
- Project name:New Construction Project of ISO7 Cleanroom for Pharmaceutical Industry
- Customer information: A medium-sized manufacturing enterprise in the pharmaceutical industry in Saudi Arabia.
- Core Demand: To build a 800㎡new clean production workshop complying with pharmaceutical industry standards, meet the clean environment requirements for pharmaceutical production, ensure compliance, pass authoritative acceptance, and guarantee the safety and stability of production.
- Project Level: Cleanliness Class ISO7 (in line with ISO14644 standard), supporting GMP workshop specifications, meeting FDA acceptance requirements.
- Delivery cycle: From scheme design, material procurement, on-site construction to commissioning and acceptance, the whole process of delivery is efficiently completed to ensure the customer starts production on time.
As the contemporary society attaches more importance to the quality of food and medicine production environment, the demand for clean rooms (GMP workshop) is also increasing. This clean room we built in Saudi Arabia in 2021 years with clean grade ISO 7 and it has been approved by FDA and started pharmaceutical production in 2022.
Project Key Challenge
The compliance acceptance standards of pharmaceutical industry are strict (needing to pass FDA certification), which directly affects product quality and production qualifications. Once the clean environment fails to meet the standards, it will lead to production suspension and product scrapping.
The customer needs to build an 800-square-meter clean workshop, with high customization requirements for the structure of cleanroom walls and ceilings to adapt to its own production layout; at the same time, it is necessary to ensure that the air purification system of the cleanroom is efficient and stable, meeting the ISO7 cleanliness requirements, and balancing practicality and compliance.
SZ-PHARMA Customized Solutions
Core Design Idea: Combine the customer's pharmaceutical production process, optimize the layout of the clean area, realize the reasonable separation of people flow and material flow to avoid cross-contamination; according to the 800-square-meter site size, accurately plan the division of clean areas to ensure the smooth connection of production processes, and reserve space for future expansion to improve the flexibility of workshop use.
Meeting Core Indicators
- Cleanliness Indicators: Stably meet the ISO7 cleanliness standard, the indoor suspended particle detection value is ≤352000 particles/m³ (particle size ≥0.5μm), which is better than the requirements of ISO14644 standard, with no obvious particle exceeding, meeting the clean requirements of pharmaceutical production.
- Supporting Indicators: The temperature and humidity fluctuation is controlled within ±1℃/±5% RH, and the pressure difference is stable at 10-15Pa to ensure the stability of the production environment; the HVAC system is equipped with high-efficiency filtration devices, and the air change rate meets the ISO7 requirements, effectively maintaining the compliance of the internal environment of the cleanroom; the walls and ceiling panels have good tightness, without air leakage or dust leakage.
Achieving Customer Demands
- Compliance Aspect: The project successfully passed the authoritative FDA acceptance in 2022, fully complying with the GMP specifications and ISO14644 standards of the pharmaceutical industry, successfully helping the customer obtain the pharmaceutical production qualification and ensuring the customer's legal and compliant production.
- Production Aspect: The 800-square-meter ISO7 cleanroom was put into production smoothly, meeting the customer's clean environment requirements for pharmaceutical product production. There was no production suspension or product scrapping caused by unqualified cleanliness during the production process, ensuring production continuity; the customized structural design and layout planning adapt to the customer's production process and improve production efficiency.
Suzhou Pharma Machinery Co.,Ltd.
2022/01/18
Lucy
