Top 5: MECART Cleanroom Projects of 2022
The MECART team is looking forward to an incredible 2023, but before we go headfirst into the new year, let’s reflect on some of the most exciting projects from 2022 and celebrate achievements of working collaboratively with our clients.
Here is a look back at 2022 through the lens of 5 MECART cleanroom projects.
1. CLASS 10,000 CLEANROOM FOR SMT MANUFACTURING IN A SEMICONDUCTOR FAB
- LOCATION: Alberta, Canada
- INDUSTRY: Semiconductor / Microelectronics / Electric Vehicles
- APPLICATION: Printed Circuit Board and Surface-Mount Technology Assembly
- SIZE: 9,000 square feet
- CLEANROOM CLASS: Class 10,000 (ISO 7)
Our client is a clean technology company specializing in technologies that enhance the motor and battery capacities of electric vehicles (EV).
Highly detailed processes and controlled environments (cleanrooms) are essential to manufacturing semiconductors for electric car components, as even the tiniest dust particle or contaminant can corrupt a component and render it non-functional.
To scale production, the client sought high-quality cleanroom spaces for its surface-mount technology (SMT) and printed circuit board (PCB) assembly lines.
MECART provided more than 9,000 square feet of Class 10,000 cleanroom space (ISO 7 cleanroom) for PCB and SMT manufacturing. It’s the client’s most extensive cleanroom construction to date!
A couple exciting features of this cleanroom project include an open ballroom cleanroom design and a bay window wall to give a showroom appearance.
2. MRNA AND PLASMID DNA MANUFACTURING CLEANROOM FOR A BIOTECH CDMO
- LOCATION: Alberta, Canada
- INDUSTRY: Biomanufacturing / Biotechnology
- APPLICATION: DNA Plasmid and mRNA Manufacturing
- SIZE: 2,300 square feet
- CLEANROOM CLASS: ISO 6, ISO 7, and ISO 8 (GMP Compliant)
Our partner, a Canadian biotech contract development and manufacturing organization (CDMO), needed multiple cleanroom spaces for manufacturing mRNA and plasmid DNA to enable the development of vaccines.
The partner’s biomanufacturing facility contains an ISO 6 fill/finish suite, three ISO 7 manufacturing laboratories, an ISO 7 master cell banking cleanroom, and an ISO 8 gowning room.
The total size of the cleanroom area is 2,300 square feet. The mRNA and plasmid DNA manufacturing cleanrooms are GMP compliant, thanks to multiple manufacturing features such as cleanroom coving, doors and pass-throughs with an interlocking system, and flush finish design.
3. COMPOUNDING CLEANROOM FOR PHARMACEUTICAL MANUFACTURING
- LOCATION: Quebec, Canada
- INDUSTRY: Pharmaceutical Manufacturing / Sterile Compounding /
- APPLICATION: cGMP Manufacturing of Non-Hazardous and Hazardous Drugs
- SIZE: 4,500 Square Feet
- CLEANROOM CLASS: ISO 6, ISO 7, and ISO 8 (GMP Compliant)
This pharmaceutical manufacturing company has contacted MECART to provide more than 4,500 square feet of cleanroom spaces divided into three distinctive areas for the company’s compounding facility:
- Non-hazardous sterile compounding cleanrooms
- Hazardous sterile compounding cleanrooms
- Powder containment cleanrooms
The compounding cleanrooms and the powder containment cleanrooms are all in operation under ISO 6, ISO 7, and ISO 8 classifications, but most of the cleanroom spaces are under ISO 7 cleanliness level.
All the cleanrooms that MECART has manufactured have been built to respond to the current good manufacturing practices (cGMP) strict guidelines and USP 797 and USP 800 chapters of the United States Pharmacopeia Regulations.
4. VACCINE RESEARCH CENTER FOR DEVELOPMENT AND CLINICAL TRIALS
- LOCATION: Canada
- INDUSTRY: Vaccine Production / Biotechnology / Biomanufacturing
- APPLICATION: Vaccine Research / Vaccine Clinical Trials
- SIZE: 9,000 square feet
- CLEANROOM CLASS: Grade B and Grade C (GMP-Compliant)
During our annual review of projects delivered in 2021, we showed you the first part of a significant vaccine plant construction project in which MECART supplied all the cleanrooms dedicated to the mass production of vaccines.
Part 2 of this project is underway. MECART has again been selected to supply all the cleanrooms for the vaccine research center where research and development activities and the vaccine clinical trials will take place.
The Vaccine Research Center exclusively uses cleanrooms that are up to the standards set out for Grades B and C, as recommended by the most recent version of the Good Manufacturing Practice (GMP) guidelines.
The overall surface covered by Phase 1 was 14,000 square feet, and the cleanrooms in the most recent phase covered 9,000 square feet, for a total of 23,000 square feet of cleanroom space.
To learn more about GMP Facilities, read our related articles:
- Building a GMP Facility: 8 GMP Cleanroom Requirements
- GMP Facility: Understanding Grade A, Grade B, Grade C & D
5. USP 800 Non-Sterile Compounding Cleanroom + Supporting Areas
- LOCATION: Southern Florida, U.S.
- INDUSTRY: Compounding / Pharmacy
- APPLICATION: USP 800 Non-Sterile Compounding Cleanroom
- SIZE: 2,300 square feet
- CLEANROOM CLASS: ISO 5 & ISO 7
Our customer, which specializes in direct-to-patient healthcare, owns an online pharmacy platform that delivers high-quality and affordable drugs throughout the United States.
The customer inquired with MECART about obtaining 2,300 square feet of cleanroom space for its USP 800 non-sterile compounding pharmacy in South Florida. That cleanroom space would help enable the company to continue its expansion.
The cleanroom environment is divided into multiple rooms for a total of five compounding rooms and four supporting areas such as the gowning areas, a washing station, and a positive pressure corridor that serves as a background zone for the compounding cleanrooms.
The five compounding rooms, maintained under negative pressure, have cleanroom cleanliness levels of ISO 5 and ISO 7. The cleanroom layout consists of two weighing rooms, two mixing rooms, and a packing and shipping room.
to learn more about designing USP 800 pharmacy rooms, read the MECART article Building a USP 800 Compliant Compounding Clean Room.
The Mecart Cleanroom Checklist is also a good starting point to help you with your compounding cleanroom design.
* Please take note that the projects chosen for this article were selected based on photo availability and confidentiality rather than size or value due to the confidential nature of some cleanroom projects.
