In this new age of cannabis legality, solvent extraction methods are as wide-ranging as the products produced. Carbon Dioxide (CO2) extraction systems stand out in the crowded landscape as they offer unique advantages for medical-grade cannabis extracts. Still, the process of selecting the correct equipment for your particular setup can be confusing.
In this article, we are going to break down the entire process of selecting, commissioning, and qualifying the equipment to ensure you are producing safe, compliant extracts in the most efficient manner possible.
Good Manufacturing Practices (GMP) Factors To Consider
- Safety First: Always keep safety as a primary consideration when selecting an extraction system. Research the system’s safety features and any certifications it may have that demonstrate its compliance with safety regulations.
- Quality Requirements: Depending on the type of extracts you are producing, your system should be capable of delivering consistent results. Consider the purity and efficacy requirements for your product as well as the system’s extraction capabilities.
- Cleanliness & Maintenance: CO2 extraction systems require regular cleaning and maintenance to ensure they remain in peak condition. Be sure to investigate the type of maintenance and cleaning required for each system you are considering.
- Cost & Efficiency: Cost is always a factor when selecting any equipment, especially in the case of CO2 extraction systems. Research the different systems available to determine which is able to meet your quality requirements in the most efficient and cost-effective manner.
- Scalability: As your business grows, you will likely need to scale up your extraction system. Investigate each system’s scalability options to ensure it can meet your needs as they expand.
The Five-Step Process For CO2 Equipment Selection
Here at extraktLAB, we have designed a five-step process that considers all of these qualifying factors, making CO2 extraction equipment selection and implementation as straightforward as possible.
Step One – The User Requirement Specification
The process begins with the URS. Thanks to our interactions with various pharmaceutical companies, we have a range of templates ready and waiting to help you through this particular step, but keep in mind that these are generalized models. They typically take into account the
- API Risk Assessment
- Design Space Requirements
- Regulatory and Operation aspects
To guarantee the selection of the best CO2 extraction equipment for your particular configuration, you will need to consider inputs relating to your own set of variables concerning risk assessment, critical process parameters, and critical quality attributes that will affect the URS.
Step Two – System Classification
This step takes into account the design space and where your CO2 extraction equipment will fit. This is a whole process in itself and something we don’t need to go into great detail about right now, but it is safe to say that fact will need to be carefully considered.
You then need to consider the following classification points –
- Do your system and your equipment have a critical space requirement?
- Does your system have an impact, and if so – is it a direct impact or no impact?
Defining the parameters of these points and how they relate to your facility is a critical step in correct equipment selection.
Step Three – System Risk Assessment
Step three is the first step in the planning process. The ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) has produced world-class, scientific guidelines on how to conduct this type of risk assessment – not only in the development process (Q8) but also directly relating to risk assessment (Q9), and good manufacturing practice for active pharmaceutical ingredients (Q7).
These documents are an invaluable resource, and we highly recommend taking a thorough look at them. Understanding these guidelines will help you provide a scientific rationale for your URS and your system classification.
Step Four – Commissioning Qualification And Testing Documents
This is a vital step when considering the addition of any piece of equipment to your extract processing facility. It essentially tests the functionality of each room and the systems, including each separate piece of equipment.
Obviously, each of these four steps is critical in ensuring you select the right CO2 extraction equipment. Following these steps also provides traceability of your commissioning documents back to your URS. This traceability is a key process in developing and illustrating a scientific rationale for the selection validation of your equipment and in what way this is connected to your CPP and your CQA.
It is important to understand that if you have modifications to the equipment, you will need to do a design qualification, followed by a design review. Again, this is a process that we can guide you through, but it is important to understand that the extract producer is responsible for creating a design qualification, which is then passed through the design review and then finally running through the risk assessment.
If this is the case, we suggest looking through ICH Q7 sections 1.5-1 to 1.5-6. There are a number of items that will need to be considered, but again, this is a process that we can guide you through.
By using documents such as traceability matrices, we can guide you to ensure you select the most applicable CO2 extraction equipment. In addition, all of the equipment offered by extraktLAB is compliant, making this process much simpler for you, the extract producer.
Step Five – Acceptance And Release
Once the previous four steps have been completed, you should now have a clear idea of what equipment best suits your specific CO2 extraction process. It is then time to move on to the acceptance and release process. This process is fairly straightforward; “Can the supplier deliver on the buyers’ acceptance criteria?” Ensuring all documentation required for GMP certification is available, and compliant is essential to the Acceptance Process and Release Process.
If you are looking for a GMP-compliant, fully automated Co2 extraction through distillation system, then don’t hesitate to contact us. We are committed to delivering the best service and assistance to ensure the success of your business. Thank you for considering extraktLAB, and we look forward to hearing from you.