Quality

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HMC Quality

The medical device and pharmaceutical industries rely on high-quality resources. Hence, the regulation-compliant provision of our biopolymers chitosans and chitosan derivatives is a matter of course for us and was one of the reasons for setting up our production in Germany.

This section will give you an overview about all quality related topics. For further questions please do not hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it..

 iso    traceability    gmp

qualgr    spec    Analysis


 

iso kl

HMC - Heppe Medical Chitosan GmbH is certified to ISO 9001 and ISO 13485 (including ISO 22442). We are audited at annual intervals by the notified body TÜV Rheinland. In addition to ISO standards, we also produce products according to EU-GMP-Directives, in our clean room class C. Filling of small batches under cleanroom class A is also possible.

The valid ISO certificates are available in the download area. For inquiries regarding questionaires or audits, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.. Our sales staff will be happy to contact you with our responsible person in our quality department.

 

 


 

traceability kl

In order to guarantee the utmost level of safety for you and to work in compliance with standards and regulations, our valid production processes are documented and adhered to by corresponding SOPs and protocols. In addition to a careful selection of our raw materials with traceability to the fishing grounds and intensive incoming inspections, we subject the production and our end products to strict monitoring and quality control. Analyses are performed in-house and at approved laboratories according to valid methods. Conformity of our Chitoceuticals® lines to ISO 22442-1, ISO 22442-2 and ISO 22442-3 is guaranteed and verified within audits.

For these reasons, the chitosan products you receive from us are always constant in their properties and quality and thus permanently reproducible. More than 500 customers worldwide have already benefited from our offer and our know-how. Our customers are represented worldwide in the medical technology and pharmaceutical industries.

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gmp kl

Due to the broad range of our various chitosan products, we do not have a „Standard Drug Master File (DMF)“ because we are using different processes for individual products. It goes without saying, that we will gladly provide you with relevant information for your product approval. If a chitosan DMF is required for your application, we can make it possible. Please, contact us. 

Since 2016, we have an active DMF Class IV for excipients for our ultrapure chitosan hydrochloride series with the US FDA.

Do you need a DMF or a Letter of Authorization for your product? We make it possible for you!  Please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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 QualGr kl

We provide our products in various quality groups in order to exactly matching our chitosan and chitosan derivatives to your requirements in research and industry.

For your information, we have composed the key points of our quality groups in an overview.

To see the explanation table, please click the pic.

hmc qu gr vorsch

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spec kl

We supply exactly specified products to you.

  • Valid inhouse methods allow us to manufacture our chitosans within strict tolerance limits.
  • We guarantee tolerance limits of ±2.5 % for degree of deacetylation.
  • The portion of insoluble constituents is far below 1%.
  • The ash content in our products is always below 1%.
  • The threshold value for endotoxins is below 100 EU/g for our Chitoceuticals-GMP-compliant-products.

All current product specifications are available in the DOWNLOAD area of our website.

How to find the right product? Please watch the explanation below:

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Analysis kl

The analyses for our chitosans and chitosan derivatives are performed in-house or in our approved partner laboratories. Our partner laboratories also work according to ISO 13485 standards, are accredited or have a cGMP manufacturing licence.

All analyses are verified or validated and comply with Ph. Eur. or USP. If special analyses are required for your products, we will be happy to develop the method or transfer it to your quality control department. Our quality control is equipped with the most modern analytical instruments. The staff is highly qualified and regularly trained.

We offer:

  • A batch-related certificate of analysis (CoA)
  • Analyses of heavy metals according to ICH Q3D in our contract laboratories
  • Valid methods for the analysis of germs, yeasts and fungi by our partner laboratory
  • in-house analysis of molecular weight by GPC
  • additional analyses on customer request
  • development of analytical methods for special derivatives as well as validation of these methods
  • contract analyses of chitosan samples
  • special analyses like glucan content or purity of fungal chitins/chitosans or insect chitins/chitosans

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Congress and fairs

Meet us in person 2021:

  • EUCHIS, 2021
  • CPHI 2021
  • Medica 2021
  • Asia Pacific Chitin and Chitosan Symposium, 2021, South Korea

To arrange an appointment please contact Katja Richter via sales(at)medical-chitosan.com

Contact

  • Heppe Medical Chitosan GmbH
    Heinrich-Damerow-Strasse 1
    06120 Halle (Saale)
    Germany
  • Tel.: +49 (0) 345 27 996 300
    Fax: +49 (0) 345 27 996 378
  • sales@medical-chitosan.com

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