Project: Canada ISO8 Pharmaceutical Cleanroom
Area: 8㎡
Inner height: 2.49m
Cleanliness: ISO8 (Class 100,000)
Industry: Pharmaceutical
Temperature & Humidity: 22±1℃/50±5%
Location: Toronto, Canada

What regulations must be followed when building modular pharmaceutical cleanrooms in Canada?
  When constructing modular pharmaceutical cleanrooms in Canada, several federal and provincial regulations and guidelines must be followed, particularly those related to pharmaceutical manufacturing, GMP certification, and clean environment design and operation. The main points are as follows:
I. Adherence to Canadian Good Manufacturing Practices (GMP)
1. Health Canada's GMP Requirements

As part of a pharmaceutical facility, the design, construction, and operation of modular cleanrooms must comply with the Good Manufacturing Practices (GMP) guidelines published by Health Canada, especially those related to sterile drug manufacturing.
This includes:
Cleanrooms must meet specified cleanliness levels and maintain a clean environment in both operational and "at-rest" states.
Cleanrooms and air purification equipment must undergo complete design, installation, and performance qualification/validation.
All air filtration systems (such as HEPA filters), pressure differentials, airflow velocities, and flow directions must be tested and documented.
The cleanroom must have a comprehensive environmental monitoring plan, including microbial and particle monitoring.

Project features

1.Free-standing modular structure
  The cleanroom features a self-supporting, free-standing modular design that requires no suspension from the existing ceiling and no modifications to the building structure. Suitable for space-constrained pharmacy environments, it can be customized to site conditions.

2.High-Performance Panels & Aluminum Frames

  Walls are made of high-performance rock wool steel panels, with windows installed flush on both sides to ensure a smooth, sealed surface that eliminates dust-collecting gaps. The frame uses high-strength aluminum profiles with no grooves or exposed screws, designed for dust prevention. The surface is treated with anti-corrosion electrophoresis, installed flush to the floor, providing stability, durability, and easy cleaning for long-term reliability.

● Utilizes high-performance rock wool sandwich panel walls, offering fire resistance, low dust generation, easy cleaning, and excellent sealing and insulation properties, making it particularly suitable for pharmaceutical clean areas with strict temperature and humidity control requirements, and meeting the basic requirements of pharmaceutical GMP for enclosure structures.
● The aluminum profile surface is treated with anti-corrosion electrophoretic coating, resistant to disinfectant corrosion, and suitable for long-term, high-frequency cleaning in pharmaceutical environments.
● The frame system uses high-strength aluminum alloy profiles with a dust-proof structural design that eliminates grooves and exposed screws, significantly reducing the risk of particle retention.
● The structure is installed flush with the ground, providing overall stability while balancing structural strength and ease of daily cleaning, ensuring the long-term stable operation of the cleanroom.

3.Fully transparent sliding door, space-saving
  The fully transparent sliding door maximize visibility and maintain cleanroom standards while saving space. Sliding operation avoids obstructing passageways, making it ideal for confined pharmacy areas, and ensures easy movement of personnel and materials.

4.Factory Pre-Assembly for Fast, Green Installation
  All modular components are precision-fabricated and pre-assembled in Airkey factory. On-site, they assemble like “Lego” blocks with uniform gaps and excellent airtightness, ensuring precision, smooth lines, and reduced construction waste.

Wall System: Why Choose High-Performance Rock Wool Sandwich Panels?
① From a GMP perspective
The core GMP requirements for cleanroom enclosure structures include:
●Smooth and flush surfaces
●No shedding and low particle generation
●Resistance to frequent cleaning and disinfection
●Non-combustible materials, especially critical for pharmaceutical facilities

② Advantages of Rock Wool Sandwich Panels
●A-class fire resistance: Pharmaceutical facilities have extremely high fire safety requirements, making rock wool a preferred material
●Structural stability: Resistant to deformation, maintaining long-term wall flatness and integrity
●Low particle release: Enclosed core structure with no exposed insulation material, minimizing contamination risk
●Modular compatibility: Standardized panel sizes enable fast installation and easy future expansion
③ Why Not Use Conventional Panels?
●Conventional panels are prone to aging and deformation over time
●Coating peeling or flaking is considered a potential source of contamination
●They are regarded as high-risk items during GMP inspections

Frame System: Why Choose Slotless Aluminum Profiles?
① Grooves = Contamination Risk
Conventional industrial aluminum profiles with T-slot structures:
●Easily trap dust and particles
●Are difficult to clean effectively
●Are frequently identified during GMP audits and often require corrective actions or sealing
② Advantages of High-Strength Slotless Aluminum Profiles
●One-piece smooth surface design with no spaces for particle accumulation
●No exposed screws, preventing particle generation caused by micro-vibration or loosening over time
●High structural strength, supporting floor-mounted installation and ensuring long-term stability

Floor-Mounted Installation: Why Is It Important?
●Reduces structural movement, helping maintain stable and consistent airflow
●Enables seamless integration with the floor, allowing more thorough and effective cleaning
●Eliminates bottom cavities, preventing dust accumulation and microbial growth
 

Why are modular clean room becoming increasingly common in the pharmaceutical industry?

●Reduced scope of change control and revalidation
●Shorter construction and commissioning timelines
●Flexible support for production line adjustments and capacity expansion
●Better suited to the trend of multi-product, small-batch pharmaceutical manufacturing

  Modular cleanrooms for pharmaceutical applications aren't simply "simplified cleanrooms," but rather cleanroom solutions that achieve faster delivery and lower change risks while meeting GMP compliance requirements.