qualifications

we qualify without limitation
any systems and process equipment

We offer qualification not only for individual systems or equipment, but also in the form of a comprehensive coverage of qualification work for new projects.

In the initial stage we can prepare for you:

 

    • User requirement specification (URS)
    • Risk Analysis (RA)
    • Impact Analysis (IA)
    • Project Qualification (DQ)
    • Validation Master Plan (VMP)

In the next stages we can offer participation in:

 

    • Factory acceptance testing (FAT)
    • Site acceptance testing (SAT)

The qualification itself is then carried out sequentially in all stages:

 

    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Process Qualification (PQ)

Depending on individual customer requirements, assistance in the preparation of process validation (PV) is possible. We also offer our participation in the defence before the auditor or regulatory body.

I want to cooperate

WE OFFER A FOLLOWING SCOPE FOR EQUIPMENT AND SYSTEMS QUALIFICATION

Clean utilities

PW – purified water

WFI – water for injection

PS – pure steam

CA – compressed air

CN – compressed nitrogen

CO – compressed oxygen

Thermal processes

Sterilization – sterilizers, tunnels

Thermal sanitation

SIP system

Process equipment and systems

Storage tanks / reactors / product pipelines

Lines for solid dosage form

Lines for liquid dosage form

Temperature/humidity mapping

Warehouses

Refrigerators / freezers

Incubators

Stability chambers

Computer control systems

Embedded control systems

WMS

MES

EBR

Other services

Validation supervision

Consultation

Preparation/check of validation documentation

references

We are a reliable partner
not only for the pharmaceutical industry.

View references

get in touch

You have an individual requirement
or an idea and you don’t know how to proceed?

Always something extra in order to help you.
Impartial view and experience
from dozens of companies.
From idea to implementation.
We are here to help you.

Contact us

GET IN TOUCH

A few reasons why working with us is worth it:

  • Always something extra in order to help you.
  • An unbiased view and experience from dozens of companies.
  • From idea to implementation. We can help you.