Environmental Validation: A Case Study on Reducing Costs for Mapping Chamber, Warehouse and Equipment Temperature, Humidity

Performance Validation is a leading supplier of pharmaceutical support services. One of the company's services is environmental validation, including stability chambers, warehouses, and equipment used for developing, processing and storing drugs, reagents and biological products to ensure compliance with FDA, cGMP and international quality standards.

Since 2007, Performance Validation has used Veriteq's temperature and humidity validation/mapping system to help their client companies in the Pharmaceutical and Life Science industries save on time and costs in validating critical environments.

“With the Veriteq validation system, we can do a better job and save our client companies money. That gives us a competitive edge.”
Mark Christiansen, Validation Specialist
Performance Validation

Performance Validation switched to Veriteq's validatable data loggers and streamlined equipment qualification, chamber and warehouse validation project costs by over 40%.

Economical Environmental Mapping: Temperature & RH

Environmental chambers are enclosures in which temperature, humidity, and other environmental conditions can be controlled. During validation, each factor must remain within an acceptable range, both over time and throughout all parts of the chamber. To verify this, chambers and rooms are mapped using multiple temperature and humidity sensors spread evenly throughout the space.

Mark Christiansen, a Validation Specialist with Performance Validation, notes that until recently, thermal validation was made more difficult by the bulky thermocouple-based equipment. Says Christiansen, “Many pharmaceutical companies are slowly realizing that thermistor equipped loggers are here to stay.”

Christiansen adds that the most commonly used recording systems can sometimes exacerbate the difficulties of validation. A conventional recorder the size of a laser printer is placed outside the chamber and is connected with wires to sensors inside the chamber. In most cases, thermocouple probes are used as temperature sensors. Data is recorded and displayed outside the chamber.

This validation equipment has a number of shortcomings:

• The size of traditional recorders, peripheral equipment such as calibrators, and thermocouple wire makes the system cumbersome difficult to move and set up;
  
  
• Breaching a door seal with the sensor wire decreases the stability and uniformity of chamber conditions. It can also introduce contaminants. The smaller the chamber, the greater this problem can be;
  
  
• Thermocouple systems are extremely error-prone and require frequent re-calibration (pre-calibration and post-calibration) to ensure reliable results. Periodically, these errors cause validation work to be repeated, an expensive process that can cause even more costly delays;
  
  
• Wires are difficult and time consuming to string. They can be a safety hazard and necessitate long periods of downtime;
  
  
• Relative humidity (RH) measurement requires additional instrumentation that can be expensive because only a few humidity points can typically be monitored in any one application.

The Veriteq Solution: Validation Made Easy & Efficient

Veriteq's environmental validation system saves costs, calibration expense and downtime with the following benefits:

• Thermistor equipped data loggers use no external wires and are easily portable and simple to set up. Thermistors offer greater accuracy and long-term stability. They also eliminate the need for pre-cal and post-cal work.
  
  
• Because there are no wires, no breaching of the chamber door seal is needed. As a result, the recording system does not disrupt chamber conditions.
  
  
• Veriteq's data loggers have an extended recording capacity, and retain data for up to twenty years without power, virtually eliminating the risk of data loss.
  
  
• Veriteq's relative humidity data loggers set industry standards in their accuracy and stability. They are made to resist air-borne contaminants and condensation, which plague most RH measurement tools.

According to Mark Christiansen, some Performance Validation employers were skeptical about Veriteq's data loggers when they first heard of them, but changed their minds after a demonstration.

“Since then,” Christiansen says, “We've been getting phone calls from around the world and we are singing Veriteq's praises, because their loggers have saved our customers so much in costs and time.”

Asked to summarize the advantages of Veriteq's products, Christiansen says simply, “[With Veriteq Instruments], we can do a better job and save our client companies money. That gives us a competitive edge.”

Learn how a Veriteq Validation System can save you time and cost in your next validation project. [More...]