Meeting & Maintaining GMP Standards While Overcoming Cleanroom Design Challenges

 

 

Harsh Chemicals Resistance

• Custom steel panels engineered for high resistance to corrosive effects of harsh chemicals.
• Sealants between panels designed to withstand exposure to chemicals without deteriorating.
• Wall system allowing easy repairs, removal or replacement of panels.
• High-quality paint formulated to withstand harsh chemicals and provides an easy-to-clean surface.
• Flush-finish simplifies and accelerates cleaning process, helps upholding high quality standards over time.

Flexible System

• Design for dynamic needs of cleanroom facilities. Allows for adaptable room sizes, design configurations, and the ability to expand, downsize, or reorganize as needed.
• A clean design for fast installation and ease of use – provides a user-friendly experience for both the initial setup and ongoing operation.
• Quickly and efficiently address maintenance requirements without disrupting ongoing operations, with the convenience of integrated panels.
• A wall system design that guarantees nothing obstructs a worker when accessing utilities or conducting cleaning processes, allowing for seamless and efficient daily operations.
• Effortlessly add or remove equipment, repurposing the space to suit unique requirements.
• Wall system minimizes downtime and disruptions while maintaining a clean working environment.

GMP Design

• Modular construction offers up to 50% faster deployment time because panel manufacturing is done off-site and occurs simultaneously with on-site foundation work. (Modular.org)
• Prefabricated panels are designed once, ensuring faster delivery without unnecessary complications.
• Pre-engineering process accelerates deployment by reducing complexity.
• Modular systems allows for quick and clean installation and minimize disruptions, keeping your operations running smoothly.
• Simpler turnaround when the unexpected happens, providing more accurate on-target project delivery and meeting deadlines.

GMP Modular System

• ISO 9001 certified reflecting the highest industry standards and commitment to quality.
• Cam lock system ensures airtight integrity and high GMP standards.
• Installation process is executed with utmost precision, resulting in a clean and seamless setup.
• Lower long-term costs through improved efficiency and reduced maintenance.
• Prefabricated panels allow for a two-step construction process on and off-site, speeding up installation and time-to-market.

GMP Engineering

• Walkable ceiling design simplifies maintenance, providing easy access without disrupting your clean operations.
• Self-sustained walls independent from main building, offering significant cost reductions by eliminating the need for structural buidling modifications.
• MECART cleanroom walls load capacity allows for HVAC system installation directly on top, minimizing the need for additional support structures, reducing costs.
• In-house engineers and HVAC specialists with extensive experience in GMP cleanroom environments.
• Integrated low wall air-return built into the panels improves air circulation and simplifies the HVAC system setup, design and usage.

GMP Design

• Flush-finish design provides seamless, easy-to-clean surfaces supporting the highest GMP cleanroom standards
• 4 to 8-inch thick steel panel wall system integrating critical utilities and systems into the panel itself (such as air returns)
• Precision-crafted coving eliminates tricky angles, minimizing dust and particle accumulation
• Proprietary CleanWeld sealant technology used to maintain strong, durable bonds that can withstand the harshest chemicals
• Customized design options, including variable heights within a single room, contribute to HVAC cost savings and adaptability

Vaccine Manufacturing Facility Cleanrooms

• 14,000 sqft built under 5 months
• Cleanroom grades: B, C & D
• 4 different ceiling heights minimizing operational costs
• Subculture room, media preparation room, packaging room
• Client greenlit 10,000 sqft phase 2 expansion

cGMP Medical Device Manufacturing Clean Room 

• 20,000 sqft cleanroom built in 4 months
• Cleanroom grades: B & C
• Stand-alone cleanroom with self-supportive structures
• Wall system supports HVAC and 30 offices mezzanine
• Custom panels for easy maintenance access and equipment replacements

Biotech CDMO MRNA & Plasmid DNA Manufacturing Cleanroom

• 2,300 sqft cleanroom facility
• Cleanroom grades: B, C & D
• Fill/finish suite, manufacturing labs, master cell banking room
• Modular cleanroom built-in structure counters lack of ceiling strenght

Panel Data Sheet

Crafted from 16-gauge galvannealed steel in 4”, 6”, and 8” thicknesses, MECART’s panels offer noise reduction with an STC of 35, R-16 thermal insulation, and can support a walkable ceiling with 20 lbs/square foot. Built-in air return systems optimize space, and panels are pre-engineered for utilities, meeting rigorous fire resistance standards and GMP requirements with a highly scratch-resistant, chemically resistant finish.

Cleanweld Data Sheet

Proprietary CleanWeld sealant is used to achieve a robust, dependable bond and seal between walls, ceiling panels, accessories, moldings, and trims. This two-component, ultra-white, high-strength structural blend offers non-flammable properties, environmental friendliness with no VOC content, and resistance to weathering and chemicals. With a fast curing time of just 60 minutes, CleanWeld is the ideal choice for various cleanroom bonding and sealing applications.