Comprehensive monitoring of audit-relevant environmental parameters
Audits, checks, norms: There are few commercial areas which are as strictly regulated and monitored as the pharmaceutical sector. As a leading measurement technology specialist with almost 70 years’ experience, we know what challenges that involves in your daily work and internal processes.
Our complete solution: The testo Saveris Pharma environmental monitoring system.
Holistic system comprising sensors, software and services
Seamless recording and documentation of all audit-relevant environmental parameters
Compliant with GxP and 21 CFR Part 11
With the environmental monitoring system testo Saveris Pharma, you have the certainty that your measurement data are recorded securely and regulatory requirements reliably fulfilled. And with the good knowledge that you have made the right decision, you can concentrate on the really profitable tasks.
Compliance and data integrity: You can count on that
Redundant data storage: Logger, Base & database / software
Strong user management with authentification
Choose between two software packages:
PRO Software: Ideal for automated and seamless environmental monitoring of cross-location areas which are subject to less strict regulations
GxP Software: Validatable according to the GAMP5 regulations and compliant with the American FDA’s 21 CFR Part 11 as well as the common GxP guidelines. Ideal for strictly regulated and audited environments, in particular involving the pharmaceutical industry.
Compliance & conformity with FDA 21 CFR Part 11 and GxP guidelines
testo Saveris Pharma is used in medical, bio-technical, chemical and pharmaceutical laboratories and cleanrooms. Our customers depend on the system in order to monitor important environmental parameters, maintain high quality standards and ensure traceability.
testo Saveris Pharma in R&D features:
Reliable, automatic and continuous checks and monitoring of temperature, humidity and differential pressure
Support in the adherence to different internationally valid quality standards such as Good Laboratory Practice (GLP) or DIN EN ISO 17025
testo Saveris Pharma has been used for years in these environmental conditions and rooms:
Facilities for animals
Stability test chambers
Blood and tissue banks
In addition to this, the system monitors the temperature and humidity of appliances:
One of the most important applications of testo Saveris Pharma is the monitoring and documentation of the environmental conditions in the production of drugs, medication, APIs, bio-pharmaceuticals, tissue samples or medicinal products.
In production, testo Saveris Pharma features:
Central and uninterrupted documentation of measurement data
Comprehensive alarm management for fast reaction in cases of limit value violation or other critical system deviations
A holistic solution comprising sensors, software and comprehensive GxP services for cleanrooms, production, aseptic filling, packaging, intermediate and final storage of APIs, ancillary substances and finished products
The validatable environmental monitoring system corresponds to the ERES principle (Electronic Records, Electronic Signatures), and is thus compliant with the requirements of 21 CFR Part 11 for automated systems.
Well-known customer worldwide depend on testo Saveris Pharma not only in production – the system is also found in attached logistics centres, in order to adhere to international standards.
Our customers are thrilled that Testo not only provides the system for logistics applications, but also fully supports them in calibration, mapping, qualification and validation in the following areas of application:
testo Saveris Pharma is used in the health sector to protect the safety of patients and reduce the risk of product loss and compliance violations, through uninterrupted and regulation-conform documentation.
In the operating theatres and treatment rooms of a hospital
For protecting the samples in blood and tissue banks
For norm-compliant environmental conditions in cleanrooms
In in-house dispensaries where sensitive medication is produced and stored
testo Saveris Pharma is also used in the health sector for the monitoring of temperature and humidity in appliances: