Cleanrooms on Demand

cGMP compliant cleanrooms and related services designed to accelerate early phase manufacturing capabilities.


As you are looking to start your cGMP journey, lack of manufacturing space or cGMP capabilities can be a major hurdle to overcome.

To address the unique needs of start-ups in your position, Azzur Group offers cleanrooms on demand to support production for early-phase partners, helping you accelerate your time to market.

Truly unique to the industry, our on-demand services include cGMP-compliant cleanroom space, warehousing, and materials management to allow partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations. 

Unlike working with a CMO, Azzur’s solutions mitigate risk, affording you full access and control to your IP, space, and activities, backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders. 

 

What Sets Us Apart


 
 

Our services include:

 

ISO 7/8 cleanrooms with ISO 5 BSCs

 

Material storage

  • Ambient Storage (15 - 30°C) 
  • Refrigerated Storage  ( 2 - 8°C) 
  • Freezer Storage (-20°C) 
  • Ultra-Cold Storage (-80°C) 
  • Cryogenic Storage (-196°C)


Raw material sampling and testing

  • Sampling under ISO 5 conditions (BSCs) 
  • ID testing using RAMAN and FTIR 
  • pH testing
  • Conductivity testing


Additional offerings

  • Equipment receipt, installation, calibration, qualification, and maintenance
  • Quality management, including implementation of phase-appropriate GMPs 
  • Project management and technology transfer 
  • Environmental monitoring
  • Training
  • Records management
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"With Azzur’s on-demand cleanroom, material sourcing, and on-site material storage, we leveraged a cost-effective solution that extended the runway for our early-phase project. Azzur Group’s “hybrid” model is indeed ideal for sponsors who wish to leverage in-house expertise in a safe, timely, and compliant manner." – Rick Ong, Head of Quality Assurance, Synlogic
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