GMP Pharma Engineering

GMP compliant in technology

  • Implementation of your technical projects
  • Necessary regulatory requirements (e.g. specifications)
  • Project tendering & monitoring
  • Qualification & commissioning
  • Compressed air measurement with the aircheck4
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Your advantages with us as your partner

We support you competently in the implementation of your technical projects by developing optimal, time- and cost-efficient solutions for you, taking into account GMP compliance and real process sequences. From the definition of the necessary regulatory requirements in the form of specifications, through project tendering and project monitoring, to qualification and commissioning, we are on hand to advise and support you in all matters. We are always independent of the supplier on the side of our customers.

Project management services:

  • Concept development for new buildings, e.g. with regard to media systems and clean rooms
  • Creation of user requirement specifications (URS), requirement and functional specifications
  • Support in the preparation of tenders and the awarding of contracts
  • Advice on the design of GMP-compliant system concepts and individual technical solutions
  • Preparation of all necessary risk analyses (e.g. according to ICH Q9 standard)
  • Monitoring the progress of the project
  • Implementation and monitoring of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
  • Support with qualification, validation and commissioning
  • Carrying out calibrations

Your technical profit

On the basis of risk analyses, we develop your strategy in accordance with Annex 1 for implementing the regulatory requirements for the CCS (Contamination Control Strategy).

In addition, we use this analysis to create valuable planning documents for implementation:

  • Technical maintenance plans
  • Hygiene maintenance plans
  • Monitoring plans for room monitoring and media monitoring (water, gases)

When it comes to planning modern monitoring systems (using state-of-the-art measurement technology), we see ourselves as your partner in the development of feasibility, procurement, installation and validation.

Qualification & validation

One of our main focuses when working with customers is the pragmatic, risk-based approach to planning and carrying out the qualification and validation of equipment, process plants, building services, manufacturing processes, cleaning and computer systems. We are equally at home in the laboratory developing and validating test methods.
As an example of our innovative planning and implementation of validations, we have, in cooperation with a friendly specialist company
developed our aircheck4. A unique precision measuring device in the GMP market for the holistic quality measurement of compressed gases (compressed air/nitrogen) under the conditions of Annex 1 or DIN 8573.

You may be familiar with such measurement processes: The cumbersome results measured with different devices are interpreted in a variety of ways. This is a particularly difficult undertaking when measurements with indicators are only “black and white”.

Do you also face a major challenge every time the measuring ranges of many tubes are outside the total oil content specified in ISO 8573-1 for class 1 or 2? That doesn’t have to be the case.

Say goodbye to cumbersome measurements with countless devices: In future, measure your own compressed air quality in the network easily and reliably with just one device that is TÜV Süd-certified and a fully validated system.

All parameters in one measuring device:

  • Dew point measurement
  • Oil vapor measurement
  • Particle concentration measurement
  • Pressure measurement
  • Qualitative measurements
  • Air sampling

Product presentation: AIRCHECK4

Your advantages

for measurements with the aircheck4

  • Simply concrete results & reports

    The values measured with the Aircheck4 are concrete and immediately available as a PDF.

  • Convenient connection

    All parameters in just one device – easily connected using quick-release couplings.

  • Compact & clean

    The aircheck4 can easily be carried as hand luggage on an airplane and does not cause any unnecessary contamination at the measuring point.

  • A single point of contact

    All individual components come from the cooperation partners SUTO-iTEC and Experts Institut. For repairs and calibration of the aircheck4, you benefit from a dedicated contact person.

Time saving

Save min. 30% time and measure an identical air in your network.

Simple

Software-guided measurements can be carried out without special qualifications.

No laboratory analysis

The determination of oil vapor eliminates the need for time-consuming laboratory analysis.

No loss

By relieving the pressure gases, you avoid unnecessary loss.

  • Buy
  • Aircheck 4
  • Air sampler
  • Accessories
  • on request
  • Service
  • 4 measuring points / measuring day
  • + 1 max. 6 / day
  • Microbiological sampling
  • on request

DEW POINT MEASUREMENT

  • Large measuring range from -100°C to +20°C thanks to unique multi-sensor technology
  • Long-term stable, reliable measurement methods
  • High precision with an accuracy of ±2 °C
  • Calibration with traceability to national standard

OIL VAPOR MEASUREMENT

  • Latest photoionization detector (PID) with self-calibration
  • Broad measuring spectrum of oil vapor concentrations
  • High precision with 5 % of the display ± 0.003 mg/m3 accuracy
  • Traceability to qualified precision gases from certified manufacturers

PARTICLE CONCENTRATION MEASUREMENT

  • Measuring method according to ISO 8573 standard
  • Particle size 0, 1 to 5.0 μm
  • The latest laser detection technology
  • Smallest particle size 50 % according to JIS, larger 100 % according to JIS

PRESSURE MEASUREMENT

  • State-of-the-art sensor technology
  • Additional quality data about the compressed air system

QUALITATIVE MEASUREMENTS

  • Dräger short-term tubes for
    • oTotal oil content
    • oCO content (in nitrogen)
    • oCO2 content (in nitrogen)
  • Fast and targeted measurement of various substances

AIR SAMPLING

  • Germ collection through impaction process
  • Sampling head autoclavable / disinfectant – resistant
  • Germ collection over 90 mm – Sedimentation plates

Examples of compressed air applications

Our workflow

Kick off

Tell us about your specific request using our contact form and get to know us without obligation.

Determination of requirements

Your contact person will address your challenges and work with you to determine your requirements. This can be done online or on site.

Expertise

Benefit from our experienced consultants who will provide you with comprehensive and successful support for your project.

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