Parameter Generation & Control specializes in humidity and temperature control products and services for the pharmaceutical industry. We understand that in FDA regulated environments there is no room for error in monitoring or measurement. We have over 30 years experience providing:
- Stability storage equipment
- ICH-validated off-site stability storage services
- ICH-validated contingency storage management
- Validation and compliance services
Pharmaceutical Rooms, Chambers & Conditioning Systems
Parameter’s precise control and distribution for stability chambers allows for problem-free mapping validations. Equipment is reliable, cost effective, and has low energy requirements.
Parameter Precisely Controls:
- Control constancy – Parameter provides precise single point humidity and temperature control (±0.5% RH / ±0.2°C).
- Uniformity across the conditioned space – Parameter provides a tight uniformity by engineering optimal distribution systems that evenly disperse the air through a conditioned area.
- Sensor Accuracy – Parameter utilizes high grade humidity and temperature sensors and maintains the calibration over the range of conditions required.
Parameter Equipment Commonly Used
- Reach-in Chambers
Various sizes of reach-in chambers that provide relative humidity control to ±0.5% RH and temperature control to ±0.2° C.
- Walk-in Rooms
Versatile modular rooms that can be configured to a specific application or size requirement. These rooms will also maintain ±0.5% relative humidity control and ±0.2° C temperature control.
- Conditioning Systems
The same conditioning systems we provide for the walk-in rooms can also be applied to existing rooms, chambers or manufacturing processes.
Pharmaceutical Stability Storage
Parameter provides a full range of stability storage services for the pharmaceutical industry. From off-site stability storage chambers to contingency management of your own stability studies, Parameter knows the industry, the requirements and the regulations. Read more about Parameter Storage.
Contingency Storage Management
Parameter’s stability storage rooms and chambers are fully validated to meet strict temperature, humidity and uniformity controls. With conditions that meet International Conference on Harmonisation (ICH) guidelines, the chambers and rooms are monitored 24/7 and provide a regulatory compliant facility within a cGMP environment. Read more about our back-up storage plans.
Validation and Compliance Services
Parameter’s validation services group can provide turn-key cost effective solutions to your validation and compliance challenges. Whether it is the challenge of setting up a validation or qualification program or an emergency response to a critical compliance situation, our validation services team will respond to your needs with proven resolution, expertise and confidence. Read more about Parameter Validation & Compliance Solutions.