Washing of critical processing equipment in medical cannabis production

In 2018, more than six new countries announced medical cannabis legalisation, patient numbers increased by 40% month on month and more than 150 million euro was invested in the European cannabis industry. Moreover, the European cannabis industry grew more in the first six months of 2018 than in the previous five years, according to “The European Cannabis Report”.

Public, political and professional opinions are also becoming more in favour of legalisation and the future of the European cannabis industry has never looked more positive.

Globally, supply has risen to meet the demand, and the competition is expected to increase which will result in lower prices. At the same time, the cannabis industry is becoming one of the most highly regulated industries in the world - on par with finance and healthcare.

Compliance
Like any other certified medicine in Europe, medical cannabis needs to live up to the highest level of standards and traceability. Therefore, GMP is crucial in the cultivation and processing stages of medical cannabis production. This higher set of standards has already delayed many international companies entering Europe, and generally, cannabis businesses often fail if they are not able to comply with the regulations of security, labelling, testing, storage and transport.

Product quality
The expectancy of high quality and regulated products is increasing. As stated in The European Cannabis Report: “Questions from regulatory bodies and healthcare professionals regarding the use of pesticides in cultivation, the prevalence of bacteria in labs and the quality of storage facilities will be integral to the success of medical cannabis facilities”. Therefore, it is crucial to have the equipment and machinery that can ensure safe and uniform reproduction of batches.

Ken Hygiene Systems
Ken Hygiene Systems deliver washing solutions to hospitals, laboratories, pharma and the food industry. "Concretely, we are involved in solving washing problems in connection with cannabis production - especially the challenges of washing the “resin-like” substance from API’s left on drying carts and in processing equipment from grinders, scissors etc," the team with the company explains.

"Our solutions also focus on requirements for elimination of risk of cross-contamination between the cultivation and the production/laboratory, as well as requirements for documentation, traceability etc.  Among others, we offer a washing solution that has access from two zones from where equipment can be loaded and unloaded after wash. The washer shifts the water between the different phases, it is drainable, and it can disinfect equipment as well as itself so that cross-contamination is eliminated."

According to them, the EWD is a standard machine, and trolleys are customized to take necessary equipment such as drying trays, trimmer parts, grinder parts, as well as greenhouse equipment, and if allowed by the layout of the factory also laboratory equipment.  

Documentation and certification
The KEN Cart Washer Disinfectors have a level of “standard” documentation according to the Council Directive 93/42/EEC with supplement 2007 /47 /EC (Directive for Medical Device Class lI b products).

"Furthermore our business system has been certified according to EN ISO 9001: 2008, EN ISO 13485: 2003 and EN ISO 14001: 2004.

The washers are tested and approved in accordance with +200 requirements resulting in - among other things:

  • Meeting requirements for data integrity
  • Providing automatic audit trail functions
  • Safe cleaning by surveillance of washing arm rotations and rotation speed
  • Full traceability of FDA approved components
  • Authorised inspection and qualification of welding
  • A risk-based approach in compliance with GAMP5" 

For more information:
Ken Hygiene Systems
+45 62 63 10 91
industrial.ken.dk  


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