Welcome to IG-Pharma GmbH

The young, dynamic team of IG-Pharma Ingenieurgesellschaft für Pharmatechnik mbH
is looking forward to supporting you with many years of experience

Our Philosophy

Satisfied Customers – the basis for a long-term partnership
Satisfied Employees – our most valuable asset

We are happy to present our extensive services to you in a meeting.

Please contact us

Our Services

Qualification

DQ (Design Qualification)

Conception phase (specification)
- URS (User Requirement Specification)
- FS (Functional Specification)
- Specification documents

Realization phase (implementation)

FAT (Factory Acceptance Test)
Accompaniment and supervision of the installation and commissioning
SAT (Site Acceptance Test)

Verification phase

IQ (Installation Qualification)
- From IQ plan to IQ report
OQ (Operational Qualification)
- From OQ plan to OQ report
PQ (Performance Qualification)
- Validation
- From PQ plan to PQ report
Final report

Measurement technology during commissioning and for existing systems

DIN EN ISO 14644 and EC GMP Annex 1
Cleanroom classification
Filter leak test (supply and exhaust air)
Air flow (smoke studies)
Recovery time
Differential pressure / pressure cascade
Temperature and humidity

Validation

Computer validation according to GAMP

E.g. for SPS, system controls

Cleaning validation

E.g. riboflavin test, microbiological imprint test

Measuring Technology

We offer the following measurements according to DIN EN ISO 14644, EU GMP Annex 1, DIN EN 12599 and VDI 2083 sheet 19

Measurements, room monitoring and mapping

Cleanroom classification
Filter leak test (supply and exhaust air)
Airflow
Recovery time
Differential pressure / pressure cascade
Temperature and humidity
Volume flow / air exchange
Room monitoring and mapping
Sound pressure
Illuminance
Tightness of containments

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

Flow visualizations

Rooms
Work places
Insulators

Commissioning of HVAC systems according to DIN EN 12599

Commissioning and adjustment of HVAC systems

Employees

Our employees are current with the latest developments, skills and new technologies required for the pharmaceutical field. Our employees can be available to your company as temporary contracted employees for the duration of a project. Your organization also has the option of integrating IG-Pharma employees into your organization for longer periods of time through fixed-term employment contracts.

Company History

1990

Founding of Steinbeis Pharmatechnik by Prof. Ronald Ziegler, then Dean of the University in Sigmaringen for the course of studies in pharmaceutical technology.

2006

Founding of the business premises in Ingelheim..

2010

Foundation of the IG-Pharma Ingenieurgesellschaft für Pharmatechnik mbH, managing director Frank Wotjak. Processing of the project business via the Ingelheim branch.