Pharmacy Industry Cleanroom in USA

• Project Name: ISO Class 5 Clean Room Construction Project for the Pharmaceutical Industry
• Customer Information: Pharmaceutical Supplier in the USA
• Core Demand: Construct an 800-square-meter pharmaceutical clean room in the USA, including key ISO Class 5 clean areas. The core demand is to select high-quality materials that meet GMP standards to ensure stable compliance with cleanliness levels.
• Implementation Cycle: 2017-2019
• Project Level: Cleanliness Level (including key ISO Class 5 areas) + Supporting Standards (GMP compliance, U.S. pharmaceutical industry clean room specifications)

Project description：

This USA Pharmacy cleanroom has parts ISO5 area, so the important is the key factor in your choice of cleanroom material. we choose stainless steel GMP panel walls (standard materials are galvanized steel, naturally),professional anti static elevated floor ,and cleanroom ceiling with full of FFU units(for keeping clean grade ISO5).

We also design the double-glazed glass wall on one side of the cleanroom , the double-glazed glass wall thickness 50mm,75mm,100mm, matched with sandwich panels of the same thickness.The double-glazed glass walls with an enhanced sound insulation of 40 dB.（better than single glazed glass）

They allow to see into the production process and create a different, working atmosphere. In this way, you avoid staff feeling isolated in small, closed rooms and thereby their safety is increased by an easier supervision of their workstations.

Project Key Challenge

The pharmaceutical industry has strict requirements on the cleanliness level of clean rooms, especially ISO Class 5 areas, which directly affect pharmaceutical production quality, and material selection is the core to ensure cleanliness; at the same time, it is necessary to comply with GMP specifications and local U.S. pharmaceutical industry standards, with extremely high compliance requirements; static interference must be avoided during production, and attention must be paid to both personnel work experience and safety supervision to prevent staff from feeling isolated in closed spaces and reduce potential safety hazards.

The total area of the clean room is 800 square meters, including key ISO Class 5 areas, and it is necessary to ensure stable compliance with cleanliness levels through material selection and equipment configuration; double-glazed glass walls need to be designed on one side, which must be matched with sandwich panels of different thicknesses (50mm, 75mm, 100mm), while meeting the sound insulation effect of more than 40dB, taking into account visualization, sound insulation and space atmosphere creation; the total project cost needs to be controlled at 300,000 US dollars to achieve a balance between quality and cost.

SZ-PHARMA Customized Solutions

Core Design Idea: Combined with U.S. pharmaceutical industry specifications and customer needs, plan the layout of the 800-square-meter clean room, clearly divide key ISO Class 5 areas and conventional areas, and give priority to ensuring the cleanliness performance of ISO Class 5 areas; take material selection as the core, match professional equipment and personalized design, not only meet GMP compliance requirements, but also optimize personnel work experience and safety supervision, and control the total project cost within 300,000 US dollars to achieve the unity of compliance, practicality and economy.

Key Technology Implementation: To meet the needs of ISO Class 5 clean areas, select stainless steel GMP panel walls (the conventional standard material is galvanized steel, upgraded to stainless steel on demand to improve cleanliness and corrosion resistance), matched with professional anti-static raised floors to effectively avoid static interference and ensure pharmaceutical production safety; the clean room ceiling is fully equipped with FFU units to continuously deliver clean air and ensure stable compliance with ISO Class 5 cleanliness; design double-glazed glass walls on one side, providing three thickness options of 50mm, 75mm and 100mm, which are accurately matched with sandwich panels of the same thickness, with the sound insulation effect improved to 40dB, better than single-glazed glass. It not only realizes production process visualization, but also optimizes the working atmosphere, facilitates staff supervision, reduces the sense of isolation caused by closed spaces, and improves work safety.

Compliance Adaptation: Fully follow U.S. pharmaceutical industry clean room specifications and GMP standards. Material selection, equipment configuration and construction processes all meet local compliance requirements. The cleanliness indicators of ISO Class 5 areas meet industry standards, ensuring that the project can smoothly pass local U.S. pharmaceutical industry compliance acceptance after commissioning and guarantee the compliance of pharmaceutical production.

Meeting Core Indicators

Cleanliness Indicators: The total area of the clean room is 800 square meters, among which the cleanliness of key ISO Class 5 areas is stably up to standard. The suspended particle test value is better than U.S. pharmaceutical industry standards and GMP specifications, effectively ensuring the cleanliness of the pharmaceutical production environment; the stainless steel GMP panel walls, anti-static raised floors and FFU units operate stably, further improving the stability of the clean environment.

Supporting Indicators: The sound insulation effect of the double-glazed glass walls reaches 40dB, better than single-glazed glass, meeting the sound insulation needs; the thickness of the glass walls (50mm, 75mm, 100mm) is accurately matched with the sandwich panels, and the installation is flat and standardized; the total project cost is accurately controlled at 300,000 US dollars, achieving a balance between quality and cost; the anti-static raised floors effectively eliminate static interference and ensure production safety.

Achieving Customer Demands

Compliance Aspect: The project fully complies with U.S. pharmaceutical industry specifications and GMP standards, the key ISO Class 5 clean areas meet the standards, and it has successfully passed local compliance acceptance, which can be directly put into pharmaceutical-related production and use to ensure the compliance of pharmaceutical production.

Production and Personnel Aspect: The double-glazed glass walls realize the visualization of the production process, optimize the working atmosphere, reduce the sense of isolation of staff, and at the same time facilitate work supervision and improve the safety of staff work; the anti-static design and high cleanliness environment effectively avoid pollution and static hazards during pharmaceutical production and ensure the smooth progress of production.

The project was successfully delivered within the agreed cycle (2017-2019). The cleanliness, sound insulation effect, material quality and compliance all met the core needs of the customer, winning high recognition from the customer and conforming to the production and operation needs of the pharmaceutical supplier.

What can Suzhou Pharma do?

1. Acceptance Guarantee: Free of charge to cooperate with customers to complete local U.S. pharmaceutical industry compliance acceptance and ISO Class 5 cleanliness testing, ensuring that all indicators meet the standards and helping the project to be commissioned smoothly.

2. After-Sales Guarantee: Provide 1-year free maintenance + 7×24-hour technical response, provide professional guidance on the use and maintenance of FFU units, anti-static floors and double-glazed glass walls, and solve various operational problems in a timely manner.

3. Compliance Guarantee: Fully comply with U.S. pharmaceutical industry specifications and GMP standards, provide complete material testing reports, construction acceptance data and cleanliness testing reports, and ensure that the whole process of the project is compliant and traceable.