Helle Pharma

PharmaEvent

Brand	Weisstechnik
Category	Pharmaceutical stability testing
Subcategory

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Consistent compliance with stability tests
Medicinal products are subject to particularly strict guidelines in order to ensure patient safety and efficacy. With our stability testing systems, you can determine the conditions under which pharmaceutical substances have the longest shelf life in accordance with compliance regulations. The spectrum ranges from laboratory-scale systems to walk-in climate chambers for optimum long-term testing. The functionality of all systems is based on a risk-based approach and with all the necessary device functions for ideal GMP compliance.

Description

The PharmaEvent series was specially developed to meet the requirements of stability testing laboratories in the pharmaceutical industry. The systems are available in four sizes and ensure a constant climate (types C/280, C/600, C1300 and C/2000) or a constant temperature (types T/280, T/600, T/1300 and T/2000). They can also be used for changing climates. The robust design, innovative product functions, precise control system, and intelligent controls enable stability testing with maximum safety and ease of use. The work area easily meets the requirements of ICH guideline Q1A. Documentation according to FDA 21 CFR Part 11 and EU GMP Annex 11 and compliance with ICH guidelines Q1A and Q1B as well as the requirements of WHO, FDA, and CPMP are a matter of course for us.

Absolute homogeneity thanks to ideal air flow – even with loaded devices
Sterile steam system for killing any microorganisms that may be present
GMP-compliant user management with AuditTrail
Alarm system according to GAMP
Operation from the workstation without additional software using the integrated WEBSeason®
Multilingual operation
Connection to our Simpati Pharma monitoring system; can also be integrated into LIMS systems