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.
testo Saveris Pharma: Functions and advantages
Measurement parameters: testo Saveris Pharma monitors these parameters
The function
Automated and uninterrupted measurement and documentation of:
- Temperature
- Humidity
- Differential pressure
Further parameters can be flexibly integrated into the system.
Your advantages
- Reliable monitoring of relevant parameters
- More flexibility thanks to easy expansion of the system
More security: Fully automatic and with minimum effort
The function
- Complete automatic recording, transmission and storage of the measurement values
- Alarms and documentation according to pre-definition, with no manual effort
Your advantages
- More security thanks to automation and ability to react in real time
- Highest possible level of reliability thanks to a minimum of manually necessary actions
- Savings of costs and time thanks to low resource involvement
Alarms: In real time and via various channels
The function
- Real-time alarms in case of limit value violations and critical system events
- Optical warning signals on data loggers and Base station
- By SMS, e-mail and as a notification on smartphone, tablet or PC
Your advantages
- Alarms and reaction in real time: Intervention before damage occurs
- Location-independent alarms and access at all times and from anywhere
Scalability: testo Saveris Pharma adapts to your needs
The function
- Unlimited scalability: With just one system, you effortlessly monitor numerous measurement sites at different locations around the world and acknowledge alarms
- Browser-based cockpit for location-independent access to the measurement data and alarms
Your advantages
- Best possible transparency over GxP relevant environmental parameters
- Scalability from local to global in just one system, for more flexibility
- Location-independent access for more efficiency.
Compliance and data integrity: You can count on that
The functions
- Redundant data storage: Logger, Base & database / software
- Strong user management with authentification
- Audit trail
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.
Your advantages
- Compliance & conformity with FDA 21 CFR Part 11 and GxP guidelines
- Validatable software (according to GAMP5)
- Uninterrupted and tamper-proof documentation
Sensors, software, services: Secure and worry-free all round
The functions
- Excellent fusion of hardware, software and services
- Testo is your partner: In installation, commissioning, calibration and qualification, up to GxP-specific services such as validation
Your advantages
- Everything from one provider – with one contact partner for all project-related topics
- Components and services perfectly coordinated for more synergy effects
- Extensive service offer:
- Project management
- Installation and commissioning
- Site Acceptance Test
- Thermal and periodic mapping
- Calibration and recalibration
- Hardware and software validation as well as revalidation services
- Software updates as well as hardware backups
- Training
- Hotline and exchange instrument service
Together, we define your individual testo Saveris Pharma service package.
Modular and flexible: Ready for every application
The functions
- Like modular building blocks, testo Saveris Pharma adapts perfectly to your conditions
- Communication standards supported: WLAN, LAN and testo UltraRange (radio)
- Connections for various digital and analog probes
- Digital probes with a minimum servicing effort
- Robust, strong radio signal with extraordinary range
Your advantages
- Whatever you intend to do: The system adapts and grows with the task
- Probe calibration during continuing operation without loss of data
- Secure coverage of all applications and measuring ranges
Backwards compatible: Innovation meets proven technology
The functions
- Compatibility of the new Base station of the 3rd generation testo Saveris Pharma with the previous generation of the testo Saveris Pharma system is no problem
- A replacement of the entire system is not necessary in order to use the new Base
- Further replacement of new hardware components step-by-step
Your advantages
- Safe decision: Service and updates beyond 2026
- More efficient measurement: Integration of the new modular testo Saveris Pharma data loggers
- Improved scalability. Smooth integration of up to 1000 data loggers and 3000 measurement channels
- More security: SMS alarms via LTE stick
testo Saveris Pharma: The components
Click on a system component to find out more about it
Every data logger can be flexibly combined with the three communication modules (WLAN, LAN, testo UltraRange)
- testo 150 TUC4: Four connections for digital probes via Testo Universal Connector
- testo 150 TC4: Four connections for thermocouples for applications in extreme conditions
- testo 150 DIN2: Two connections for standard probes via miniDIN for using the comprehensive Testo probe range
- testo 150 T1: Internal NTC temperature sensor for monitoring temperature
The communication modules
The communication modules allow the use of different communication technologies with the testo 150 data logger modules:
- Existing infrastructure (WLAN or LAN/Ethernet)
- testo UltraRange long-range radio technology
Even after commissioning, communication and data logger modules can be flexibly connected with each other and exchanged.
- The heart of the environmental monitoring system testo Saveris Pharma
- testo UltraRange functionality via additional communication module
- Management and analysis of the measurement values of up to 3,000 channels
- GxP-compliant alarms in cases of limit value violations or critical system events via integrated LED or connected alarm provider (via relay)
- Integrated emergency battery for highest data security in case of power cut or other system malfunctions
The Gateway and the testo UltraRange technology
The gateway
Access point and transmission support for communication via the independent radio network testo UltraRange with encrypted, proprietary signals.
testo UltraRange radio technology
- Developed for use in buildings
- Excellent range and signal robustness
- Depending on the customer’s wishes, the connected components are wirelessly updated
- For the smooth integration of other measurement parameters (e.g. differential pressure)
- 4 – 20 mA connection via the testo 150 TUC4 data logger module
- Standardised interface for easy integration
The digital and analog probes
Digital and analog temperature and humidity probes for high-precision measurements of GxP-relevant parameters in a regulated environment.
- Measuring range from -200 to +1300 °C for almost any possible scenario in the pharmaceutical sector
- Probe exchange in seconds without data gaps in the documentation
- Easy handling and installation
- Efficient system monitoring with digital door contacts
Transmitter for humidity and differential pressure
- Integration of further physical measurement parameters (e.g. humidity or differential pressure) into the testo Saveris Pharma system
- Ideal solution for highest accuracy and for special applications (high humidity, trace humidity, etc.) in compressed air, drying and air conditioning technology as well as in cleanroom applications
The testo Saveris Pharma software is available in two different versions:
- PRO Software: For automated and seamless environmental monitoring of cross-location areas which are subject to less strict regulations
- GxP Software: Validatable version with Audit Trail, electronic signatures and user levels with differing user rights (conformity with 21 CFR Part 11)
Additionally, the testo Saveris Pharma cockpit is available:
- Web-based and intuitive user interface
- Identify and acknowledge alarms at any time, location-independently and from any end device (smartphone, tablet, PC)
- Platform-independent data access
- Integration of individual floor plans for easy and fast localization of measurement locations and alarms
testo Saveris Pharma: The application areas
Smooth processes and convenient documentation
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:
- (Research) laboratories
- Cleanrooms
- Facilities for animals
- Greenhouses
- Stability test chambers
- Bio-banks
- Blood and tissue banks
In addition to this, the system monitors the temperature and humidity of appliances:
- Refrigerators, deep-freezers, ultra-deep-freezers, liquid nitrogen applications
- Other laboratory equipment such as water baths
Safe production of sensitive pharmaceuticals
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.
More security in storage and transport
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:
- Warehouses and distribution centres
- Incoming goods
- High-bay warehouse
- Refrigerated rooms
- Refrigerators, deep-freezers, ultra-deep-freezers, liquid nitrogen applications
Certainty for hospitals and pharmacies
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:
- Refrigerators, deep-freezers, ultra-deep-freezers, liquid nitrogen applications
- Incubators
Certainty, security, precision: Your advantages with testo Saveris Pharma
Holistic solution comprising sensors, software and services:
An experienced company. A reliable contact partner. Proven technology.
Seamless recording and documentation of all relevant environmental parameters:
You can rely on the uncompromising functionality of the system.
Compliant with GxP and 21 CFR Part 11:
No buts – testo Saveris Pharma works strictly according to the most important requirements.
Alarms in real time:
Whatever happens – the system informs you immediately so you can intervene in time.
“Continuation of data is absolutely key to us. The high rate of redundancy of the testo Saveris Pharma system was one of the key factors in selecting Testo and its solution as a supplier.”
Operations Lead Inventory Manager of a Top 10 pharmaceutical company
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