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Hamilton On-Line


News

 

ACCREDITED LABORATORY IN HUNGARY

     We are pleased to announce that the Microbiological Laboratory of J.S. Hamilton Hungaria Kft. on the 16th of November 2016 received the accredited status by the National Accreditation Authority (NAH) under the registration number NAH-1-1801/2016 and was registered until 15th November, 2021.

 

Besides being a Full Member of the International Laboratory Accreditation Cooperation (ILAC), the National Accreditation Authority (NAH) has also received the subscription right and has signed the Multilateral Agreement (EA MLA) of the European Accreditation (EA), so the analyses of the Microbiological Laboratory are accepted not only in Hungary but also abroad.

 

The National Food Chain Safety Office has licensed the operation of the Microbiological Laboratory on the 27th June, 2016 under the registration number 131/2016/Lab/NÉBIH.


 

 

 

Medicinal products and starting materials
 

Medicinal products and starting materials

 

 

Laboratories of J. S. Hamilton Poland S.A. offer a broad range of products and raw materials analysis for domestic and foreign manufacturers and distributors of pharmaceuticals.

As a private and independent from industry we are leaders in this field on Polish market.

Our offer covers both routine analysis procedures for manufacturer’s quality control as well as analytical services for development, implementation and validation including transfer of analytical methods for our clients’ applications.

We offer analytical service of raw materials, excipients, active ingredients, packaging, intermediate and finished products. To satisfy our customers needs we continuously improve our service by implementation of new analytical methods in compliance with pharmacopoeia and ICH.

Pro- healthy role of dietary supplements has recently caused rapid expansion of their consumption worldwide. Consequently, in the result of growing demand for their testing we have developed specific analytical testing related to dietary supplements in all the stages of their development, validation and quality control studies.

 

Accreditations and Approvals

J. S. Hamilton Laboratories demonstrate high-tech research background, highly skilled staff supported by state-of-art testing and analytical equipment.
However, testing of pharmaceutical products would not be possible without accreditations and approvals. To this end our laboratories have following accreditations and approvals:  

Permission for quality control testing (physical and chemical) of medicines issued by Main Pharmaceutical Inspectorate in Warsaw, Poland.

Accreditation of Polish Centre for Accreditation for compliance with PN-EN ISO/IEC 17025 international standard requirements (Certificate No. AB 079).
Approvals of our main customers in accordance with their individual acceptance procedures.

 

Confidentiality

Both our internal procedures and written contracts with our customers assure full confidentiality of testing results and all data exchange in our communications. We understand importance of confidentiality in pharmaceutical industry.


Our testing and analytical equipment is constantly upgraded and expanded to meet  our customers’ requirements. At the moment we use following equipment:
  • HPLC with UV-VIS (PDA), RI, FLD, ELSD detection
  • UPLC with UV-VIS (PDA) and FLD detection
  • GPC
  • GC with FID, ECD, NPD, PFPD, TCD, MS and MS-MS detection
  • Headspace  and P&T GC
  • ICP-OES and ICP-MS spectrometer
  • UV-VIS spectrophotometer
  • FT-IR spectrophotometer
  • CV-AAS mercuric analyzer
  • Dissolution bath
  • Disintegrator bath
  • Stability chamber for stability checks in the following condition: 25oC/60%  RH,
  • 30oC/65% RH and 40oC/75% RH, which are control and monitor for 24 hours

 

Offer

Development and Validation

Our services cover development and validation of analytical methods for raw materials, packaging, active ingredients and finished products by use of chromatography, spectroscopy, spectrometry, electrochemistry and elemental analysis, and include:

  • Identification of chemical substances
  • Assay
  • Purity testing
  • Residual solvents (OVI)
  • Heavy metals testing
  • Dissolution profile
  • Disintegration testing
  • Stability studies
  • Cleaning validation, including traces of active ingredients and residual preservatives

 

Implementation of Analytical Methods:
  • Optimization of analytical methods
  • Transfer of the methods.

 

Quality Control
  • Testing according to SOP
  • Certification of research results
  • Testing of raw materials in compliance with EP, FP and USP

 

Routine Analysis to ISO Standards, Pharmacopoeia and In-house Methods

 

 

 

For more information please contact us at hamilton@hamilton.com.pl

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