Climatic test cabinets

Cold stores

Production and
manufacturing facilities

Store rooms and warehouses

Transportation

Pharmaceutical industry,
 tablet and power ERH

Sample Retain Room - Ambient

Maximum Temperature Distribution - Bottom Level
              Dated 15/03/2004 to 18/03/2004

• GAMP 4
• 21 CFR PART 11 compliance monitoring system
• FDA, HACCP
• Validated Software and Hardware Monitoring System with documented IQ/OQ/PQ

• Best Direct NIST Traceability via Two Pressure & Two Temperature Humidity Generator Standard Following NCSL-RISP-5 Guidelines
• Reference Chilled Mirror Hygrometer with reference to ASTM D4230-83 Reference Mapping Methology & Guide Line
• 1612 Pharmacopeial Forum Vol 29(5)
• 1079 Good Storage and Shipping Practices
• 1118 - Monitoring Devices - Time , Temperature and Humidity
• 1150 - Mean Kinetic Temperature For Pharmaceutical Stabilit
• IEC60068xxx, AS, ASTM standard Test Method for Environmental and
  Temperature Chamber

• 1612 Pharmacopeial Forum Vol 29(5)
• 1079 Good Storage and Shipping Practices
• 1118 - Monitoring Devices - Time , Temperature and Humidity
• 1150 ? Mean Kinetic Temperature For Pharmaceutical Stabilit
• IEC60068xxx, AS, ASTM standard Test Method for Environmental and
  Temperature Chamber

Validated Monitoring Result

Validated Data Logging
Software

Hot Air Exhaust

Compliance

Traceability

Reference Mapping Methology & Guide Line