Helle Pharma

PharmaEvent walk-in stability test chambers

Brand	Weisstechnik
Category	Pharmaceutical stability testing
Subcategory

Contact Sales

Consistently uncompromising in stability tests in almost unlimited chamber sizes
Medicinal products are subject to particularly strict guidelines worldwide. With our stability testing systems, you can determine the shelf life of pharmaceutical substances extremely safely and in accordance with legal requirements. The spectrum ranges from laboratory-scale systems to walk-in climate chambers for optimum long-term testing. All systems have the necessary documentation options according to FDA 21 CFR Part 11 and EU GMP Annex 11 and comply with ICH guidelines Q1A and Q1B.

Description

The highly accurate and reliable PharmaEvent stability test chambers are validatable and specifically designed to enable you to meet the requirements of ICH guideline Q1A. Also other national and international requirements such as WHO, FDA, and CPMP are met. The insulating cells can be optimally adapted to the existing building structure because there are no fixed dimensions. The standard height is 2,700 mm; other dimensions are possible. Test chambers and test spaces with a volume of 10–800 m³ are available.

Stability testing, easier and safer than ever:

Ideal for integration into your building
Absolute homogeneity thanks to ideal air flow – even with loaded systems
Energy-efficient construction
GMP-compliant user management with audit trail and alarm system according to GAMP
Operation from the workstation without additional software using the integrated WEBSeason®
Multilingual operation
Connection to the Simpati pharma monitoring system; can also be integrated into LIMS systems