Azzur of New England has been a partner to the biopharma and medical device industries since 2012, providing professional services in various areas of the product development and commercialization lifecycle. Recently, we observed recurring problems related to startup of GMP operations for early phase manufacturing. Some of these problems include, inadequate space due to the “shoe-horning” into general office buildings, poor controls due to sharing of the HVAC/BMS with other tenants, construction delays, warehousing issues, and cleanroom certification failures.
Based on this, Azzur of New England has created a new offering, Facility Solutions, to address these problems for early phase partners, looking to transition into a GMP organization.
Problems We Can Solve:
Facility Solutions provides certified and qualified move-in-ready cleanroom environments for early phase GMP manufacturing. We refer to these as Cleanrooms On-Demand, that allow for a compliant GMP space for our partners to utilize for executing manufacturing activities. These cleanrooms can be rented on a monthly basis, and are designed for fully disposable, small to medium scale early phase manufacturing processes. Also included are the necessary access & security controls and facility programs (pest control, cleaning, environmental monitoring, waste management) and quality management to ensure compliance with regulatory standards.
Facility Solutions also provides qualified and controlled material storage space. Material storage is offered at a wide range of temperatures and is fully supported by our facility infrastructure that includes an controlled access & security system, backup electrical power, a validated controlled environment monitoring system, a qualified warehouse, and a variety of qualified controlled temperature units (CTUs). Also included is the ability to test and release materials in our Materials Testing Lab. We are also able to ship materials to and from our facility in a controlled manner.
Whether your needs are long-term or temporary, our Facility Solutions remove the burden of facility build-out/renovation/maintenance, allowing you to focus on delivery of critical therapies to patients.
How What We Offer is Different:
Facility Solutions is different for the following reasons:
- It is purpose built for the health-care life sciences industry, specifically early phase biopharma and medical device companies
- It is designed and maintained by people with significant GMP experience
- It is designed to be flexible and accommodates a wide variety of customer-types
- It is conveniently located in Waltham, MA with easy access to both Rt. 128 and Cambridge, MA
- Additional services related to calibration, maintenance, equipment qualification, quality management, and records management are readily available on-site.
Summary of Solutions:
Our Facility Solutions include:
- ISO 7/8 Cleanrooms On-Demand
- Material Storage
- Ambient Storage (15 – 30°C)
- Controlled Temperature Storage (20 – 25°C)
- Refrigerated Storage (2 – 8°C)
- Freezer Storage (-20°C)
- Ultra-Cold Storage (-80°C)
- Cryogenic Storage (-196°C)
- Raw Material Sampling/Testing
- Sampling under ISO 5 conditions (BSCs)
- ID testing using RAMAN and FTIR
- pH testing
- Conductivity testing
Our additional services include:
- Equipment Receipt, Installation, Calibration, Qualification and Maintenance
- Quality Management, including implementation of phase appropriate GMPs
- Project Management and Technology Transfer
- Environmental Monitoring
- Records Management