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- Calibration
  
  We are one of the leading calibration laboratories in Germany and accredited for more than 300 calibration procedures according to DIN EN ISO/IEC 17025:2018.
  Calibration
- Our measured variables
  Our accredited laboratories cover almost all measurands and offer a unique service portfolio.
- On-site calibration
  We calibrate test equipment and measuring points at our customers' sites with professional competence and high-precision equipment.
- Calibration equipment
  With our portable calibrators for temperature, humidity and pressure, calibrations can be carried out regardless of location.
- Test equipment management
  
  We manage your test equipment with the holistic PRIMAS test equipment management solution for compliance with standards and directives.
  Test equipment management
- PRIMAS online & mobile
  The internet-based test equipment management system PRIMAS online supports the assurance of test equipment requirements - even while on the road.
- PRIMAS validated
  PRIMAS validated is a validation-enabled test equipment management system for companies with GxP compliance requirements.
- PRIMAS exchange
  PRIMAS exchange enables automated data transfer of test equipment data between MES/CAQ systems and our data master.
- PRIMAS connect
  PRIMAS connect is a web service for automated access and queries to PRIMAS online in the Testo Industrial Services data system.
- Qualification
  
  We support qualification projects such as cleanroom qualification or plant qualification. We also qualify warehouses and transport systems according to GDP and GSP standards.
  Qualification
- Cleanroom
  Professional support for all GMP measures in the area of cleanroom qualification - from conception to implementation.
- Plants & Utilities
  Risk-based qualification of process plants, supply systems and utilities for the sustainable safety of process stability and robustness.
- Transport and storage
  Storage and transport qualification to ensure uniform temperature and climate conditions and maintain product quality.
- Validation
  
  We take care of cleaning, process and transport validation as well as computer and software validation to ensure reproducibility and robustness.
  Validation
- Cleaning validation
  Holistic handling of professional cleaning validations as well as support for validation projects and revalidation measures.
- Process validation
  Risk-based process validation to demonstrate the fulfilment of process requirements and outcomes, and to ensure product quality.
- Transport validation
  Transport validation to ensure stable climate conditions during logistics and transport of sensitive goods to the consumer.
- Computer Software Validation
  Computer system validation and software validation (CSV) to ensure the reproducibility of procedures and processes of computer-based systems.

Der neue Annex 1 – Änderungen für Reinraumqualifizierung

Der Fachartikel fasst die Neuerungen des Annex 1 (08/2022) zusammen und gibt Handlungsempfehlungen zur Anpassung bestehender Überwachungsstrategien im Reinraum. Veröffentlicht in der ersten Ausgabe der cleanroom & processes im März 2023.

GMP-gerechte Dokumente und Überwachung im Reinraum gemäß DIN EN ISO 16444

Im August 2022 erschien der überarbeitete Annex 1 „Manufacture of Sterile Medicinal Products“ der „Volume 4 EU Guidelines for Good Manufacturing Practice für Medicinal Products for Human an Veterinary Use“. Er enthält Änderungen und Konkretisierungen im Bereich der Reinraumqualifizierung sowie zum Erhalt des qualifizierten Zustands und dem Reinraummonitoring. Zur Umsetzung fast aller angepassten Vorgaben des neuen Annex 1 ist eine Übergangsfrist bis zum 25.08.2023 definiert1 – diese Zeit muss aufgrund der Requalifizierungszyklen genutzt werden, um die Überwachungskonzepte anzupassen.

Inhalte:

Die Kontaminations-Kontrollstrategie
Unveränderte Definitionen und Anforderungen
Dezidierte Definition der Qualifizierungsumfänge
Geänderte Anforderungen bei der Klassifizierung
Änderungen beim Monitoring und Diskrepanz zur Klassifizierung
Möglicher Umgang mit der Partikelgröße 5μm in A und B at rest in der Klassifizierung

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