Kromat's Contract Research Organization using a range of OHAUS products
OHAUS equipment meeting the needs of a highly demanding pharmaceutical industry.
There is a certain range of tests that must be carried out while working on new products before they are released for sales. There are many requirements concerning, for example, pharmaceutical products as the manufacturer needs to make sure they are entirely safe before they can be used on a patient. They go through clinical trials and many different forms of testing procedures so that the producer can finally state with certainty that the products are safe for those who will use them.
In the present business environment many market players are trying to optimize their costs by taking advantage of outsourcing some of the critical functions. That is exactly what is happening in the pharmaceutical industry where the companies are increasingly looking to transfer duties and functions including manufacturing and research, with the aim of lowering significantly the costs of developing new medicines. That is why they are using the specific expertise of Contract Research Organizations.
CROs, ranging in size and scope of expertise, may provide services such as biopharmaceuticals development, biological assays performance, clinical research, clinical trials management, pharmacovigilance and final regulatory approval from the Food and Drug Administration or European Medicines Agency. CROs are being supportive of different types of companies or organizations such as privately owned companies, universities, research institutions, governmental organizations etc.
Kromat Ltd., an OHAUS Dealer in Hungary, a leader in life sciences, diagnostics and applied chemical markets with over 20 years of experience, distributing well-reputed Agilent products, has opened its Contract Research Organization – the FEPtest LabServices laboratory in Székesfehérvár to provide high quality laboratory services. Their main business scope is to analyse FEP products and substances (food, environmental or pharmaceutical) in a qualified facility in line with Good Manufacturing Practice regulations. The FEPtest LabServices is committed to providing the highest quality services and accurate results in order to meet the strict demands of regulatory authorities.
As far as the food is concerned the laboratory is marking the level of such parameters as elements, pesticides, sugar, salt, preservatives, ash, fatty and amino acids, dyes, protein and vitamins in products like meat, feed, fruits, vegetables, coffee, tea, pasta, dairy and bakery products. In case of environmental testing water, soil, sediment and sludge are all being tested for the presence of organic and inorganic compounds and elements. Last, but not least, when it comes to pharmaceutical analysis the laboratory controls the Quality of Active Pharmaceutical Ingredients and Medicinal Products. Analyses are performed according to the analytical testing procedures provided by the customers or current Pharmacopoeias (EP, USP, BP, JP).
One of the main focuses is to support pharmaceutical and dietary supplement industries by providing them with method development, validations and transfers and analytical testing procedures as well as batch release or LOT release testing. So many different procedures and products being tested for various purposes creates a need of using balances, shakers, centrifuges and vortexes on a daily basis.
What does FEPtest LabServices do in their everyday work? Among the standardized measurements and analysis that are being done are:
high-performance liquid chromatography both with UV and Diode Array Detectors (HPLC-UV/DAD)
gas chromatography with Flame Ionization Detector and Triple Quadrupole mass spectrometry (GC-FID/TQMS)
liquid chromatography Quadrupole Time of Flight (LC-QTOF)
Their job, among other things, requires them to transfer methods from one device or instrument to another, and to pursue it in compliance with Good Manufacturing Practices, meeting as well the requirements of ISO/IEC 17025:2018. FEPtest LabServices decided on OHAUS range of products supporting most of the workflows in their laboratory beginning with sample preparations up to product release.
The following OHAUS products have been deployed:
Heavy Duty Orbital Shaker (SHHD2325DG) used to prepare FEP samples. "We are satisfied with the equipment as it can handle all sizes of flasks and it's easy to use and maintain." says Tamás Tyukász, representative of Kromat's Laboratory Instruments Division.
MB120 Moisture Analyzer used for moisture determination mainly of pharmaceutical products.
Frontier 5000 Multi-Pro Centrifuge FC5816R with refrigeration. As volatile reagents and solvents are being used it is required to have a centrifuge for preparation of samples that can chill the analysed material below 0 °C. FEP samples and dietary supplements are being prepared with this centrifuge.
Explorer Semi-Micro Analytical (EX225DM/AD) and Adventurer Precision (AX423M) Balances intended for analysis of pharmaceutical products, uniformity of dosage units measurements and providing data for breakability and friability analysis. Used for qualification of volumetric apparatus and pipettes as well as measuring components requiring high precision.
Adventurer Precision (AX8201M and AX2202M) Balances applied for preparation of eluents, solvents and reagents.
"As FEPtest LabServices is a newly built laboratory, we are satisfied that the equipment we bought is the best available on the market and the products are compliant with GMP and ISO requirements." emphasizes Kromat's Laboratory Instruments Division representative, Tamás Tyukász.
What is of great importance are the unique features of the products which make them stand out in the market. To find out more about the products please click on the following links:
Explorer Semi-Micro Balances
Adventurer Precision Balances
MB120 Moisture Analyzer
Frontier 5000 Multi-Pro Centrifuges
Heavy Duty Orbital Shakers