Skip to main content
Project GMP-UPGRADE by Testo Industrial Services

GMP upgrade project

B. Braun Medical AG.

Reference

GMP upgrade project

at B. Braun Medical AG, CH Sempach

The headquarters of B. Braun Medical AG Switzerland and the Centre of Excellence (CoE) for Infection Control are located in Sempach. This is where disinfectant and sanitary preparations are developed, produced and marketed for global supply via the B. Braun Group’s sales network.

The goal of the “GMP upgrade” project was the integrated handling of all compliance-related and technical services within the production area of the Centre of Excellence for Infection Control. In addition, all optimisation, qualification and validation activities were coordinated with the customer's existing three-shift operation with the least possible impact on the production plan.

GMP upgrade project

Our scope of services

at B. Braun Medical AG, CH Sempach

  • Risk-based qualification management
  • Structuring/consulting in the field of qualification
  • Project management of all qualification activities
  • Creation of qualification documentation (LH/RA/IQ/OQ/PQ)
  • Execution of the qualification on a wide variety of systems: Preparation tanks, mobile agitators, pumps, product filters, ointment processing systems, filling plants (liquid/semi-solid), compressed air systems including distribution system, and water treatment plants
GMP-UPGRADE by Testo Industrial Services
  • Support in setting up a calibration management system
  • Support in creating calibration SOPs
  • Calibration of the measurement parameter: Temperature and relative humidity, pressure, mass and volume flow, rpm, velocity, force, and time

 

Calibration by Testo Industrial Services
  • Qualification of cleanrooms for production, development laboratory and microbiology
  • Consulting/advice in the field of cleanrooms
  • Support in creating room data sheets
  • Creation of relevant qualification plans
  • Performance of quality-related measurements
  • In the cleanroom: Filter leak test, determination of particulate cleanroom class, verification of microbiological cleanroom class, volume flow measurement/room air exchange, flow velocity, flow visualisation, determination of recovery times, qualification of sampling cabin
  • Restructuring of process validation in line with FDA guidance for industry: Process validation: General principles and practices
  • Consulting, documentation and performance of process validation
  • Planning of activities in the context of process validation
  • Staff training
  • Project management (MS project)
  • Creation of product groups and definition of reference products
  • Definition of critical process parameters and the scope of sampling
  • Coordination of validation batches
  • Creation of documentation: Validation master plan for existing processes, support in the creation of SOPs for new processes, risk analyses for specific product groups, PPQ plans for specific product groups, PPQ records and PPQ reports
  • Sampling procedure
  • Measures for process monitoring
  • Induction and training of those responsible for process validation
Process validation by Testo Industrial Services
  • Support in the review, evaluation and preparation of documents
  • Structuring the scope of qualification and validation
  • Assistance in categorisation of analytical systems in accordance with GAMP 5®
  • Optimisation/development of analytical methods for validation
  • Implementation and documentation of the validation of analytical methods in accordance with ICH Q2: GC, HPLC, Titration, TOC
  • In addition to the sub-project cleaning validation, the TOC analysis was developed within the framework of SWAB sampling and established at the customer's site
Validation of methods by Testo Industrial Services
  • Implementation of a one-day practical workshop
  • Cleaning validation for all employees in the field of cleaning validation
  • Consulting in the area of production/cleaning validation
  • Creation of a cleaning validation concept
  • Structuring of the cleaning validation activities in a primary master plan
  • Project management, resource planning and time management
  • Creation of the risk analyses analysis for cleaning validation
  • Qualification (OQ/PQ) of the CIP systems
  • Product development in the optimisation studies for cleaning the CIP systems
  • Preparation and implementation of cleaning validation plans within the defined process stages
  • Structuring and carrying out of sampling
  • Preparation of final validation reports
  • Evaluation of service life (for unclean, cleaned and sanitised equipment)
Cleaning validation Testo Industrial Services

GMP upgrade project

The result

at B. Braun Medical AG, CH Sempach

“The GMP upgrade was an excellent project from both a professional and organisational point of view. Testo Industrial Services staff was very well integrated into the project team and worked with our employees on a sound basis of trust - without fear of contact. I would particularly like to emphasise their willingness to perform and their dedication. The project was carried out at all times and without exception, no matter what time of day or night and without any complaints.”

Sandro Di Labio, Head of Quality Assurance, B. Braun Medical AG, CH Sempach

Conversation in front of the B.Braun Medical AG building

More assurance, better service for your GMP compliance

What set us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Testo Industrial Services

Our services at a glance

Your contact

Please call us at:

obligatory field *