ENGINEERING

QUALIFICATION/VALIDATION

MEASURMENT TECHNOLOGY

WELCOME TO THE IG-PHARMA GMBH

The young, dynamic team of the IG-Pharma Ingenieurgesellschaft für Pharmatechnik mbH
is pleased to support you with many years of experience

OUR PHILOSOPHY

Satisfied customers – the basis for a long-term partnership
Satisfied employees – our most valuable asset

OUR MANAGEMENT

Frank Wotjak

General manager

Fon: +49 6725 9111070
Fax: +49 6725 9110928
E-Mail: frank.wotjak@ig-pharma.de

Prof. Ronald Ziegler

Authorized signatory

Fon: +49 7152 7647910
Fax: +49 7152 7647911
E-Mail: ronald.ziegler@ig-pharma.de

OUR TEAM

Our team is made up of qualified technicians and engineers- this enables us to draw on a wealth of experience and offer our customers a wide range of services. IG-Pharma consists of about 40 dedicated employees.

OUR COMPANY HISTORY

1990
Founding of Steinbeis Pharmatechnik by Prof. Ronald Ziegler, then Dean at the University of Applied Sciences in Sigmaringen for the department of pharmaceutical technology

2006
Founding of the establishment in Ingelheim.

2010
Founding of the IG Pharma Engineering Company for Pharmaceutical Technology mbH, general manager Frank Wotjak. Execution of the project business through the Ingelheim branch.

2014
IG-Pharma GmbH assumes essential tasks from Steinbeis Pharmatechnik

2017
Relocation of the company site from Ingelheim to Gau-Algesheim

2018
Certification of the quality management system of IG-Pharma GmbH according to DIN EN ISO 9001:2015

2020
10th anniversary of IG-Pharma GmbH

OUR SERVICES

ENGINEERING

  • Technical Building Equipment
    • Client representation
      • We support you as a client in your tasks and duties as an independent representative and consultant. We have the necessary knowledge and skills and are able to support you in all matters relating to your construction activities. We review results and plausibility so that you can make competent and sustainable decisions during the development, realization and use of a building.
    • Instrumentation, control and automation documentation
      • Comparison of circuit diagrams and process and instrumentation diagrams CAD
    • Energy savings
      • Planning and implementation of energy savings for your plants. Whether reducing your energy needs or increasing efficiency. We determine your savings potential based on facts and data.

QUALIFICATION/VALIDATION

  • Planning
    • With many years of experience, we can help you to define zone concepts and plan clean rooms.
  • Documentation
    • We are pleased to support you in drawing up the following documents:
      • Requirement specifications and (user) requirements specifications (URS)
      • Master and validation plans
      • Risk analysis / FMEA
      • Work instructions and SOPs
      • Qualification documents (DQ, IQ, OQ, PQ)
      • Computer validations
      • Cleaning validations
      • Traceability matrices
      • Clean room and system qualification
    • Implementation
      • We participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for our customers. We also qualify systems, equipment and rooms and carry out GxP training courses for employees or customers.

MEASUREMENT TECHNOLOGY

  • Measurements, room monitoring and mapping
    • We carry out the following measurements for you
      • Filter seal fit/ filter leak test
      • Cleanroom classification and particles
      • Recovery time (recovery tests)
      • Volume flow
      • Differential pressure
      • Temperature
      • Relative humidity
      • Leak test of rooms
      • Sound pressure measurements
      • Light level measurements

        We also offer room monitoring and mapping for temperature, relative humidity and particles.

  • Flow visualization
  • Hygiene inspection according to german guidline VDI 6022 on HVAC systems.
  • Commissioning and adjustments of HVAC systems according to DIN EN 12599

PRIVACY STATEMENT

The IG-Pharma Ingenieurgesellschaft für Pharmatechnik mbH takes the protection of your personal data very seriously. We treat your personal data confidentially and in accordance with the statutory data protection regulations.

Our website can be used without providing personal data; we do not store any personal data.

We would like to point out that data transmission over the Internet (e.g. when communicating via e-mail) may have security gaps. Complete protection of data against access by third parties is not possible.

For all questions regarding data protection, please contact datenschutz@ig-pharma.de.

We would be pleased to present our extensive services in a personal conversation