Standard deviation has to go down to 10 procent
As of 2020, the so-called standard deviation on our products may only be 10% instead of the current 20%. In order to comply with stricter European legislation, Bedrocan will have to introduce a new processing method. The idea is to pulverize the product to ensure the end product can be mixed better and the deviation of THC and CBD will be below 10%. This new processing method is still being detailed.
|THC level packaging||22,0%||22,0%|
|Standard THC level end product||17,6% – 26,4%||19,8% – 24,2%|
De oude en de nieuwe situatie, met Bedrocan® als voorbeeld.
The jar that is issued by the pharmacy says that Bedrocan has a THC level of 22%. The current rules allow us to deviate 20% from that percentage. This means that the THC value of our end product may fluctuate between 17.6 and 26.4%. The end product Bedrocan is right in the middle of those levels. Soon, when the new European legislation becomes effective in 2020, the deviation may only be 10%. At that point, the THC value may not be outside 19.8 and 25.2 percent.
What will change?
Without modifications to the processing process, it is not possible to achieve the new standard of 10%. As the cultivation method of the plants cannot be refined any further, management is seeking a solution in mixing the cannabis. Cannabis flos, the dried flower, is too large so the end material will have to be pulverised.
The pulverised material is finer than the granulate we supply at the moment. In order to obtain finer material, we have no choice but to mechanise this step. It is not possible to pulverise by hand; you need machines that can grind the cannabis. Furthermore, Bedrocan, following the expansion at A5, will be faced with the challenge of processing larger quantities of around 10,000 kilo. At that point, it is impossible for processing to be fully manual. An additional processing step is being considered, primary processing.
The changes at a glance
- Material will be mixed to achieve the standard deviation of 10%
- No flos but a new end product, pulverised/ground flower
- Flos only upon request
- Mechanisation required to:
- Process increased quantities
- Achieve refinement
- Introduce additional processing step of primary processing
Frequently asked questions
Where will primary processing take place?
There are various options:
Primary processing will take place at A5. Material will be transported from A2 to A5. Or primary processing stays with cultivation, which means both sites retain primary processing following drying.
Will processing disappear completely from A2 if primary work takes place at A5?
We don’t know yet. Industry is likely to maintain a demand for flos. A2 will become more specialised, but that is something that is happening already.
Where will mechanisation (pulverisation/refining) take place?
Refining, grinding the cannabis, will take place at a site other than A5 or A2. It will take place near our new lab. This lab will be required to perform the tests on the pulverised material.
How does mixing work?
This process still needs to be worked out. However, the idea is that if an end product contains too much THC or CBD, we add extra plant material. If there is not enough THC or CBD, we add plant material with a higher THC / CBD content. It will always be of the same variety, so Bedrocan added to Bedrocan. We will not mix different varieties, where we add Bedrocan to Bedrolite or something like that.
Will there be enough work after the mechanisation?
Expectations are that the work can be carried out with the existing team. After the expansion, there will be more cannabis to process as the number of kilos will be doubled.
Will A2 continue to exist as a cultivation site?
For the coming years, A2 in Veendam will remain a cultivation site. Should this site become surplus to requirements or inefficient due to the continued growth of the company, it is likely to continue as a research site.
Where is Bedrocan likely to expand its cultivation capacity in the future?
Expansion of the cultivation capacity will not take place at A2 at any rate. An additional cultivation site in Emmeloord is equally not an option. Expansion will take place in the north of the Netherlands, ideally as close as possible to an electricity hub, a place where it is possible to consume plenty of electricity. It is too early to speculate about an exact location.
Preparations for expansion A5 in full flow
The preparations for the expansion of A5 are well under way. The draft design has been approved, and Project Coordinator Frane Šunjic is working on detailing the specifications for the contractor and the suppliers. Financing needs to be completed, and the German expansion plans will take precedence.
The layout of the new part of A5 will not be like the existing part and will look more like that of A2. Frane said “We’re actually going back to basics. Experience has shown that the design of A5 is just too complicated and that some processes could be simplified.” The new draft design has been devised by Tjalling, Johan and Dolf Erkelens.
What will change
Below you can read what will change in Emmeloord compared to the current situation.
- Plant-attachment systems in the production cells, also known as the ducts, will disappear. There are likely to be holes in the floor for inserting the plant stake. Below the hole there will be a drain for discharging surplus water and cleaning water. An employee will only need to insert a stake into the floor and attach the plant to the stake.
Feed-water system – The water factory returns in a highly simplified version.There will be water basins next to the production cells that will resemble the water reservoirs in Veendam.
Heating and air-conditioning system – The approach to the heating, ventilation and air-conditioning system, also known as HVAC, is less visible to personnel, but important to improving the production process. The biggest difference is that fresh air will no longer come from outside, but from a technical area. This prevents contamination like last summer, when five batches were contaminated with pesticides. With this new approach, it also becomes easier to control the indoor climate, or the temperature in other words.
When the financing for the expansion is put in place, the project team will be striving for the following schedule:
- Spring 2019 – preparations, including a temporary access door in the facade
- Summer 2019 – construction of the cells
- October / November 2019 – first clones in the new production cells
- First quarter 2020 – first harvest
How much will personnel notice of the expansion? The builders will not enter the existing cultivation area and processing areas of A5. All the construction activities are strictly separated. Special construction units will be positioned outside with a separate toilet block and canteen. However, we cannot escape the construction work producing increased noise levels. Personnel will also be given some new work instructions as to how to deal with the new work situation. Watch this space!
Fire-resistant wall needs to be sorted out
Our fire insurance requires the wall of the vegetative cell at A5 to be given an extra fire-resistant coating. The wall in drying area 2 and another wall in processing will be given the same treatment for the same reason. The work is necessary in connection with the impending expansion, as the new hall will be right behind the vegetative area. The modifications are expected to be introduced in April and May.
The work in the drying area and processing will barely cause nuisance, because the modifications will be carried out at times the areas are not in use. The situation is different for the vegetative cell, because it is in continuous use. The right time will have to be chosen in consultation with production planning. “We cannot escape the need to move tables to ensure the builders can reach the wall. Plants will be screened off properly too. It will be quite an exciting operation”, explained our Engineer Marc Meulenberg.
The extra fire-resistant coating will have to protect the steel load-bearing construction of the premises against overheating in case of a fire. The protective coating will be applied on both sides of the wall.
A new laboratory for Bedrocan
This spring, Bedrocan opens a new, ‘in-house’ Quality Control (QC) laboratory in Amsterdam. The laboratory will perform measurements that support the standardisation of our processes, making our production process more predictable. “It is the next step in the continuous professionalisation and improvement of our processes”, is how QA Director Naiem Hakiemie summarised the need for the QC lab.
As Willem Mink already informed the employees of Bedrocan Nederland and as described elsewhere in this newsletter, our standardisation process will be refined. European standards for medicinal cannabis will be tightened up, and as of 2020 our cannabis may no longer deviate 20% from the standard, but only 10%. The solution is in mixing the plant material, but that means you need to know exactly what you’re mixing. In other words, to measure is to know. “We need to determine the exact percentage of active substances in the cultivated plant material and in the mixing material”, said Naiem. “That is the only way we can determine the percentage of active substances in the final product as precisely as possible.”
With the arrival of the QC laboratory, situated in the Science Park in Amsterdam and equipped with modern Ultra Performance Liquid Chromatography (ULPC) equipment, we are able to get an even better grip on our tried and tested cultivation process. The pharmaceutical industry uses ULPC to obtain accurate and reliable analyses of the composition of mixtures. Anyone who is interested can check Wikipedia for more information, but for Bedrocan it is important that this technology provides options to analyse the composition of the plant material at various times during the cultivation process, so that it is much easier to produce an accurate prediction of the composition of the end product. Furthermore, it provides opportunities to intervene on time in case of any non-conformities.
Over the past few months, a whole host of improvements have been introduced in the production process and the arrival of a QC laboratory is a perfect continuation of the same process, as far as Naiem is concerned. “We work with live material and that has an inherent level of unpredictability. Bedrocan has an excellent reputation in the area of standardisation and we are raising the bar even further. We are getting more and more grip on our processes and that is part and parcel of producing a safe and high-quality pharmaceutical product.”
As of April, the Human Resources Department (HR) is back to full strength. The Department will consist of David Farago, who is responsible for recruitment, Henny Zuur, Senior HR Advisor and Marlinda Herbers, who was recently appointed as HR Assistant. Henny and Marlinda support both Bedrocan Nederland as well as Bedrocan International.
According to Henny, more ‘reinforcements’ are on the way in the form of a new personnel information system (Afas). With this online system that is likely to have an app, employees can access relevant information in the area of personnel matters and working conditions. “We opted for a user-friendly personnel information system that we will roll out during the course of this year. Employees can use it for information in the HR sphere, but can also introduce changes of address, submit requests for leave, submit expenses claims, view their personnel file, etc. It will be much more efficient for employees and management”, expects Henny. As soon as we know more about this system, we will come back to that in this newsletter.
In the meantime, any employee can send questions to the e-mail address of the HR Department, which is firstname.lastname@example.org.
QA finds solution for contaminated cannabis
Last summer, Bedrocan was stuck with a large batch of contaminated cannabis. Some 350 kilos had become contaminated by pesticides that had entered via the air-conditioning system. The medicinal cannabis seemed unmarketable. Until the QA department found a solution.
The cause was the extremely dry summer. A high concentration of pesticides, originating from agriculture, had stayed in the outside air and entered the cultivation cells of Bedrocan via that route. The problem occurred at A5 and A2. The medicinal cannabis was not fit for sale until the QA Department, in the person of Naiem Hakiemie, found a solution.
Wash with CO2
The solution was only found recently. By mixing the contaminated cannabis with frozen CO2, the pesticide molecules attach themselves to the CO2 and evaporate as it were. “It works like a washing machine. I put the cannabis in a mixer, add the detergent (i.e. the frozen CO2) and turn and turn and turn. The frozen CO2 melts and the contamination evaporates with the CO2.” The mixing leaves you with a fine cannabis powder, free from pesticides, that can be sold. All’s well that ends well.