Related Information

• Veriteq VL-System Overview
• vLog Software
• VL-2000 Humidity Specifications

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• White Paper on Veriteq 21 CFR Part 11 Compliance
• Thermal validation in the Pharmaceutical Industry
• Thermocouples vs. Thermistors

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• Clinical Trial Refrigerator & Freezer validation
• Pharmaceutical chamber validation
• Pharmaceutical warehouse validation
• Chamber Monitoring
• Veriteq data loggers help relocate U.S. Biotech Company

Performance Validation is a leading supplier of pharmaceutical support services. One of the company's most frequently used services is the validation of the environmental chambers used in the development, processing and storage of products to comply with FDA, cGMP and international quality standards.

Performance Validation uses Veriteq's validatable data loggers to streamline equipment qualification by forty to fifty percent.

The Challenge

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.

Mapping and recording is made more difficult by the monitoring equipment that, until recently, was the industry norm. "The pharmaceutical companies," Mark Christiansen, a Validation Specialist at Performance Validation comments wryly, "Are just realizing that transistors are here to stay."

Although the comment is a deliberate exaggeration, there is no doubt that the most commonly used recording systems add greatly to the difficulties of validation. Typically the size of a laser printer, conventional recorders are placed outside the chamber, and are 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 equipment has a number of shortcomings:

• Because of the size of traditional recorders (and required peripheral equipment such as calibrators) and the use of wires, the system is difficult to move and set up.
• The wiring that connects the recording system with the sensors inside the chamber must pass through the chamber door seal. Breaching this seal increases the difficulty of keeping chamber conditions stable and uniform, and potentially can introduce contaminants. The smaller the chamber, the greater this problem can be.
• Thermocouple systems are error-prone and their reliability is often affected by the length and quality of the sensor wiring of each chamber (see Thermal Validation in the Pharmaceutical Industry - An argument against the use of thermocouples). This necessitates frequent re-calibration (pre-calibration and post-calibration) for every application, 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. In addition, because wires are often temporary, they can get in the way and become a safety hazard, especially during large room or warehouse mapping applications.
• Relative humidity (RH) measurement requires additional instruments and sensors that are expensive and complex to set up. Because these instruments typically use thicker wires that must pass through the chamber door seals, the use of them poses an additional challenge to the stability of the chamber environment. In addition, because of their expense, only a few humidity points can typically be monitored in any one application.

The Veriteq Solution

The design of the Veriteq VL-2000 Temperature and Humidity data logger overcomes the problems with traditional recording systems:

• It is a fraction of the size and uses no external wires, so it is more portable and easier to set up.
• 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.
• The system uses on-board thermistor temperature sensors instead of thermocouples (see Thermocouples vs. Thermistors). Thermistors offer greater accuracy and long-term stability and there are no wiring errors. They also minimize the need for pre-cal and post-cal work and virtually eliminate the risk of having to repeat validations due to measurement error.
• The VL-2000 has a ten year recording capacity, and retains data for up to twenty years without power, substantially reducing the chance of data loss.
• Veriteq's relative humidity data loggers are easier to use and less expensive than traditional RH instrumentation, and won't disrupt the chamber environment. Making use of the latest in RH-sensing technology, Veriteq's RH Data Loggers also have a low margin of error, retain their accuracy over the long-term, and are resistant to air-borne contaminants and condensation. The lower cost per point also allows for more comprehensive mapping of RH conditions.

In conversation, Mark Christiansen says that 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, "They've contacted other people, and I've been getting phone calls from around the world. I've been speaking Veriteq's praises, because their loggers are the way to go."

Asked to summarize the advantages of Veriteq's products, Christiansen says simply, "We can do a better job and save customers money. They give us a competitive edge."

Veriteq Instruments provided Performance Validation with a validatable data logging package that included Veriteq VL-2000 Temperature and Relative Humidity data loggers, and vLog Software. The package, which offers the essential data security and 21 CFR Part 11 compatibility features of the previous system, is based on use of the palm-sized VL-2000 logger. This logger includes both temperature and relative humidity sensors in a single self-contained unit.