ISO 8 Packaging Room for a Biopharma CDMO

A Cleanroom for a Contract Development and Manufacturing Organization  

Our client, a global Contract Development and Manufacturing Organization (CDMO) needed a new cleanroom environment. The biopharma CDMO looked to expand its operations and one key part of this expansion was a  new packaging room.

This biopharma CDMO specializes in expedited drug development and biomanufacturing services for pharmaceutical and biotech firms worldwide. They also provide commercial cGMP manufacturing services. You don’t become a successful company by chance – you do it by developing and manufacturing quality products corresponding to your customers’ needs.

And this is exactly what Mecart does daily.  We provide custom cleanrooms with high-quality standards for our customers who require rigorous, controlled environments for their manufacturing operations.

Here is a summary of this cleanroom project:

  • Industry: Biopharma/CDMO
  • Cleanroom Class: ISO 8
  • Dimension: 750 sq. ft.
  • Location: Research Triangle Park (RTP), North Carolina
  • Application: Packaging and Sampling Room for Biopharma Products
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Packaging and Sampling Cleanroom 

The North Carolina-based new cleanroom has a footprint of  750 square feet and is divided into 3 rooms.  The cleanroom space will be dedicated to packaging and sampling operations for biopharma products.

The packaging room also includes 4 total doors –  2 regular cleanroom doors and 2 sliding doors, with flush finish windows and automatic, touch-free door operators. The doors are also equipped with an interlocking system to meet the cGMP cleanroom requirements and regulations. We can see both types of entries in the picture below.

The cleanroom is equipped with a custom HVAC and AHU system. The HVAC system will make 25 air changes per hour to keep the cleanroom to an ISO 8 level of cleanliness.


Biopharma Packaging & Sampling Room 

Packaging rooms provide pharmaceutical and biopharmaceutical companies with a clean environment to properly package drugs without the risk of contamination, thereby extending shelf life and improving overall quality.

Biopharmaceutical companies need a cleanroom environment for their packaging procedures to keep the end-products safe for the consumer. The reason is simple, a cleanroom’s purpose is to keep all the contaminants and airborne particles away from the medicine and drugs.

And choosing a modular solution for your cleanroom environment needs is a cost-effective and flexible alternative. They are easily expandable for further expansion projects, easily cleanable, and have shorter lead times than traditional construction cleanrooms.

Contact us if you are ready to discuss your packaging room project.