Welcome to the service of the L.B. Bohle Maschinen + Verfahren GmbH. Please do not hesitate to contact us in case of following questions:

  • Staff training
  • Customer trials for support in PQ
  • Re-qualification in modifying already qualified systems
  • Machine maintenance
  • System calibration
  • Change Control
  • Vibrator discharge aids testing of discharge trials

 

Your contact at the company:

Martin Nienkemper
Sales-Coordinator


GMP compliant DQ / IQ / OQ qualification

We provide implementation and document compilation for the qualification of L.B. Bohle systems. Qualification is carried out to a large extent in-house during assembly of the machine. The qualification can be adapted to meet the customer’s requirements.

DQ (Design Qualification)

Documented proof of regulations, performance data and specifications are taken into consideration during planning.

IQ (Installation Qualification)

Documented proof that the assembly of the machine is in compliance with the plans, regulations, performance data and specifications.

OQ (Operations Qualification)

Documented evidence that the functioning of the system meets the production requirements.
(initial calibration, manual mode, automatic, error messages)

Computer validation according to GAMP 5

The GAMP 4 Directive specifies various development stages of the SPS and/or computer supported control system based on the specifications to qualification according to the V model (Life Cycle Model). Bohle provides this documentation optionally and supports the customer in the validation of the entire system.

Electronic Batch Record according to 21 CFR Part 11

The employed software can be configured optionally for compliance with the FAD 21 CFR Part 11 Directive. The associated documentation describes the implementation of the individual provisions in the Directive and documents the correct installation of the software in the machine.

Benefits:

  • GMP compliant qualification
  • Cost-efficient qualification
  • Costs for qualification are already specified when purchasing the   system
  • Time-saving during implementation.

Technology CenterContinuous processing starts here

The unique feature of this plant is that the tablet production can be implemented either without granulation or with dry or wet granulation, in one system.

to Technology Center

Service CenterReliable trials

The Bohle Service Center enables the presentation and testing from our machines as well as the executions of workshops and tutorials.

to Service Center
TEST LINK