Calibration and Qualification

Calibration Services

Factory calibration certificates (ISO calibration)
General certificates (2.1, 2.2 or 3.1)

Qualification of New Devices

Qualification Documents
DQ / IQ / OQ / PQ documents
Qualification implementation (IQ / OQ / PQ)

Calibration Services


Ensure quality and reproducibility: We calibrate your laboratory equipment and document measured and reference values under specially defined conditions. Working together with you, we determine the optimal calibration intervals for your applications.

Factory calibration certificates (ISO calibration) for IKA devices

You will receive a factory calibration certificate for your new IKA laboratory or analysis device in accordance with DIN EN ISO 9001. Calibration is carried out by our Quality team, either prior to delivery or on your premises by our service team . The certificate contains up to two calibration parameters at up to two test points as proof of the device’s main function. The table below lists the main functions with the corresponding test points. Please refer to the technical data for a more detailed description of the individual products.

Typical calibration parameters:

Device Main Function Test Point
MAGNETIC STIRRER temperature*
RPM
weight*
ext. sensor
hot plate
hot plate
THERMOSTATS temperature in the bath(water)
STIRRER RPM
timer*
temperature*
drill chuck
ext. sensor
SHAKER temperature*
RPM
ext. sensor
attachment
THERMOSHAKER temperature
RPM
heating coil
attachment
CENTRIFUGE RPM rotor
VISCOSITY METER viscosity
RPM
defined medium
spindle
 
Device Main Function Test Point
CALORIMETERS RPM
temperature
weight
reactor vessel
ext. sensor
reactor vessel
ROTATRY EVAPORATOR RPM
temperature
weight
rotor
ext. sensor
in the bath(water)
DISPERSER rpm drive
MIXER rpm drive
GRINDERS rpm drive
HEATING BATHS temperature in the bath(water)
VACCUM vaccum connection side
*Only available for device versions with the corresponding function.

You are welcome to provide us with specific test points when you place your order. We will then check them for feasibility and be happy to make you a custom offer.
Regular calibration of you laboratory equipment is also important during daily operation. It's our pleasure to make you an offer for the recalibration of your devices.

Standard calibrations:
- Laboratory devices, Ident no.: 0010006579
- Analysis technology, Ident no.: 0010006580

Calibration and maintenance agreement
If you would like to have your laboratory or analysis device calibrated on a regular basis, you can take advantage of our combined calibration and maintenance agreement.

Calibration for pipettes
Accuracy and reliability are essential when it comes to pipette dispensing with routine recalibration reducing costs and liability risks. Therefore, we offer attractive calibration packages according to DIN EN ISO 8655 or DAkkS for all models in our IKA PETTE series and, upon request, also for pipettes from other manufacturers.

Calibration for ROTAVISC
For ROTAVISC viscometers, we recommend at least one annual check and calibration by our qualified service technicians. If you would like to check the viscometer yourself, we will gladly provide you with special silicone oils and an auxiliary calibration tool.

Calibration for MATRIX
For our MATRIX DELTA thermoshaker series , we recommend at least one annual check and calibration of the heating module by our qualified service technicians.

General certificates (2.1, 2.2 or 3.1)


If required, certificates for surfaces (according to 3.1) or materials (according to 2.2 or 2.1) can be issued for accessories (possibly involving additional work and costs).

Please note that acceptance test certificates in accordance with DIN EN 10204 - 3.1 must be ordered together with the respective devices and accessories. Issuing at a later date is no longer possible in most cases.

This also applies to FDA or GMP certificates, which are needed for some of our products and accessories. Please contact our sales department before ordering. We will be happy to check whether or not the required certificate for your order is available.

- Laboratory devices, Ident no.: 0010010524
- Analysis technology, Ident no.: 0010010808

Qualification of New Devices


Whatever your application, it is essential that the laboratory equipment used meets your technical specification! At IKA, we can prove that this is the case. Throughout the qualification process, we use visual, safety and functional test certificates. As such, we can confirm that your product complies with the design specifications.

This is how we support you in qualifying your devices:

1. Documents for Qualification

These documents contain everything you need for your own internal qualification:
• EU declaration of conformity
• Factory certificate (2.1)
• Factory calibration certificate according to DIN EN ISO 9001
• Factory certificate for the devices or accessories
• Proof or certificates of material (if available)

These documents are a supplement to the factory calibration certificates and verifications and are issued for each product prior to delivery.
Documents for Qualification:
- Laboratory devices, Ident no.: 0010006577
- Analysis technology, Ident no.: 0010006578

Please note that the documents for qualification must be ordered at the same time as the associated devices in order to guarantee a smooth process.

DQ / IQ / OQ / PQ – this is how IKA supports you step by step in your process validation.

DQ: Design Qualification
During design qualification, all components, assemblies, system parts, filters and controls are documented in order to prove that they correspond to the intended design and are suitable for the intended purpose.
IKA supports you in this by confirming the requirements / functional specifications or your URS (User Requirement Specification), providing technical data or through feasibility studies in our application laboratory. Depending on the work involved, costs may be incurred that will be reimbursed to you in the event of a device purchase.

IQ: Installation Qualification
Installation qualification is documented proof that the equipment, systems and components in the installed or modified version meet the previously defined requirements.
IKA supports you in this qualification step by providing the certificates and documents that confirm the identification and proper functioning and delivery of our devices. You will receive ready-made documents / checklists for the specific product, which you can check point by point on site. If required, IKA will perform the qualification step for you on site and check the installation conditions in your laboratory.

OQ: Operation Qualification
During operation qualification, the functions of the system or the equipment are checked for compliance with the requirements.
IKA supports you in this step with clear instructions for carrying out relevant functional tests and makes recommendations for suitable measuring equipment, if necessary according to the respective standard to be complied with. If required, IKA will carry out the qualification step for you on site. At the same time, IKA will provide you with important information on the qualification of your employees in order to avoid operating errors on the device.

PQ: Performance / Process Qualification
Performance qualification demonstrates that the premises and infrastructure systems, in combination with the production equipment, are suitable for manufacturing products of the agreed quality in a reproducible manner.
IKA will be happy to support you in putting your system into operation. IKA mainly assesses the proper functioning of the devices in operation and helps to adjust parameters if necessary.
The quality of the respective device is usually assessed by our customer. If required, IKA will support you on site with performance qualification.

2. DQ / IQ / OQ / PQ documents

With these documents we offer assistance for our customer's own validation of individual devices as well as complete IKA solutions.

The documents are prepared individually according to customer requirements and contain the above-mentioned DQ / IQ / OQ / PQ points.

These product-specific documents consist of detailed descriptions of the installation qualifications (IQ), operation qualifications (OQ) and process qualifications (PQ) to be carried out based on the design qualification (DQ).

If you operate different devices as a single functional unit, we will support you with all application-related questions and create individual acceptance documentation.

DQ / IQ / OQ / PQ documents are created exclusively in combination with the Documents for Qualification (1) for each device.

Standard DQ / IQ /OQ / PQ Documents for a device:
- Laboratory devices, Ident no.: 0010006581
- Analysis technology, Ident no.: 0010006582

IQ / OQ / PQ documentation and system solutions on request.

3. Qualification implementation (IQ / OQ / PQ)

We will be happy to put your new laboratory device into operation for you and check it personally on your premises using the IQ / OQ / PQ documents. This is how we ensure that it meets your specific requirements. For this purpose, we develop customized IQ / OQ / PQ documents for you as described in point 2. Especially in terms of PQ, we can check your process applications on site and prove that our laboratory device or system does exactly what it is supposed to do.

Do you want to qualify your individual process in addition to your devices? Here, too, IKA offers you support with the preparation of the PQ qualification documents and with implementation on site.

Interested? We are happy to prepare your own customized offer.
- Laboratory devices, Ident no.: 0010010802
- Analysis technology, Ident no.: 0010010801





Declaration of compliance with the order (2.1)

Factory calibration certificates (ISO calibration)

Documents for Qualification

DQ / IQ / OQ / PQ Documents



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