Extraction standards

For medical grade honey extraction, we require extractor conformance with its extraction management standards. In summary, the standards cover critical factors of the extraction process, such as the implementation of stringent cleaning programmes to ensure hygienic extraction and the control of cross-contamination of products via appropriate extraction methods with effective wax removal procedures. Extraction facilities are required to have specifically designed and controlled air conditioning and filtration systems, along with an effective pest management programme. Processing temperatures and honey filtering systems are controlled adequately with specific requirements being placed on the filter pore size (Figure 6.6). Careful consideration is given to the type of drum used for raw medical grade Manuka honey, as well as the requirements of drum storage. Overall, throughout the extraction process, product traceability is still maintained to a high standard to ensure accurate trace-back if required.

Above: Stringent medical grade honey harvesting in practice

Above: Special care for harvested honey boxes to be transported to extraction facility

Above: Medical grade honey filtration

Product testing regimes

We undertake strict testing regimes on the raw medical grade Manuka honey, using well developed in-house laboratory methods, as well as independent external laboratories for specific testing. The testing protocols involve rigorous analysis methods to ensure that products are safe and as pure as possible for inclusion in Medical Device manufacture.

Raw medical grade honey

The raw medical grade Manuka honey arrives from accredited suppliers in new, unused food approved drums with tamper evident seals. Each consignment is documented and recorded upon receipt with a batch number; a further number is issued individually to each drum, allowing individual traceability of the drums. Once documented and receipted into the system, the laboratory begins the sampling, testing and grading process.

The honey is sampled representatively by the in-house laboratory ready for analysis. Honey samples are then tested for the following; moisture content, total activity, non peroxide antibacterial activity (UMF® rating), foreign matter, sensory attributes such as Manuka typical taste and colour, and microbiological criteria, including the total plate count, and yeasts and moulds. Once test results are collaborated, each drum is individually graded against the raw medical grade Manuka honey specifications. Any drums that do not pass the raw medical grade Manuka honey specifications are reassessed for suitability within the therapeutic or food grade; if unsuitable for these grades the drums will be rejected (Table 6.1).

Processed medical grade honey

Processed medical grade honey is raw medical grade Manuka honey formulated into a batch of product for use as an ingredient in medical devices. We operate a quality management system which complies with the requirements of AS/NZS ISO9001:2000 and is also Good Manufacturing Practice certified by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE).

The raw honey is loaded in the factory and undergoes a minimal heat treatment process to ensure product quality. This heat treatment step has been carefully designed, implemented and validated, specific to the characteristics of honey, to ensure that the active Manuka content of the medical grade honey is unaffected.

The honey then passes through a fine filtration system and finally begins a homogenisation and pre-determined crystallisation process. Medical grade honey requires the best possible filtration techniques. We use very fine filters for the filtration of medical grade honey. Once the final stage of the process is completed the honey is pumped into new, unused drums which are fitted with a medical grade quality internal liner. This bag liner acts as the primary packaging and the honey is completely sealed within the liner to minimise or eliminate the risk of the processed medical grade honey coming into contact with the secondary packaging, the drum, and, more importantly, the external environment. At this stage the honey is tested for moisture content, pH level, heavy metal content, microbiological content, multi-pesticide residues (nil tolerance), 5-(Hydroxy methyl)-2- furfural (HMF) level, total activity and non-peroxide activity.

Once the honey has been cleared by quality personnel it is shipped to the Medical Device manufacturer where the honey is used as an ingredient for honey-impregnated Medical Devices. The Medical Device manufacturer operates a quality management system which complies with the requirements of BS EN ISO 13485 for the design and manufacture of medical products. The Medical Device Manufacturing Company also complies with the European Directives for medical devices in order to affix ‘Certification European’ (CE) marking on its products. Both our company and the accredited honey supply programme have been audited by the Medical Device Manufacturing Company, providing a double guarantee that the honey received as a Medical Device ingredient meets the Medical Device system requirements and specifications.

Back to top