Masy Systems is an experienced validation company and has been serving the BioTech and Pharmaceutical industry for nearly 25 years. Based on our reputation for performing the work accurately, quickly, efficiently and under a firm contract basis, Masy Systems provides environmental chamber validation services for the pharmaceutical and biotech industries, and we program and configure equipment specifically for your needs. Calibration certificates noting NIST traceability are provided for all instrumentation used to perform testing.

Primary Strengths:

• Experience – Masy only sends qualified personnel to perform these specific validation services
  
  
• Accuracy – Our temperature standards calibrated directly @ NIST
• Quality – ISO 17025:2005; ISO9001:2000
  
  
• Efficiency – A tremendous resource of equipment to meet or exceed your timeframe requirements
• Competitive pricing
• Ability to handle large and small scale projects

Autoclaves		Refrigerators
Sterilizers		Cold Rooms
		Storage Rooms
		Warehouses
Steam In Place (SIP)		Ovens
		Vacuum Ovens
		Process Ovens
		Depyrogenation Ovens
Bioreactors		Vessels
		Tanks
Lyophilizers		Centrifuges
Fermentors		Incubators
Freezers		Incubator Shakers
Cryo Storage Freezers
Shipper Containers		Stability Chambers
		Stability Rooms

Validations Based on Your SOPs:

We perform validations based on your standard operating procedures (SOPs), always considering your risk assessment vs. the level of qualification testing.

• Firm contract pricing (hourly upon request)
• We can execute your protocols or create them for you IQ, OQ, PQ or VQ
• cGMP testing and calibration of your chamber controllers
• Temperature, Relative Humidity, Pressure and CO2
• Quality Assurance Review of all documentation
• Documentation is put through a full quality review prior to submittal to customer
• Reports are in accordance with GLP and cGMP compliance guidelines
• Complete validation report package, including:
  Executed protocols, sensor calibration data, real-time mapping data, summary trends and detailed analysis of data
• All mapping data is provided in both hard copy and digital format
• Problem solving capabilities:
  Masy Systems can assist with problem resolution by recommending and implementing modifications essential to bringing your equipment into compliance