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.
HMC - Heppe Medical Chitosan GmbH is certified to 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.
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.
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.
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.
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:
The analyses for our chitosans and chitosan derivatives are performed in-house or in 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.
- 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