Path to GMP: Building and Design
In the quest to become GMP compliant, the design and flow of your manufacturing facility are critical. Mistakes in the design phase will cost money and eventual time loss, so taking this step seriously and planning to the end for every detail must be a top priority. It’s not enough for an architect to draw out what is needed; other factors, such as the flow of people and products, should be considered at every stage of designing your facility. The entire process should be created in such a way as to avoid cross-contamination and move products and people throughout the facility as safely as possible.
Today, we continue our series on Good Manufacturing Practices, discussing what you need to know about building and design and other tips and tricks for your cannabis operation to achieve GMP compliance and stay ahead of the competition.
Step 1: The Basics of GMP Design
To begin the planning process, start by laying out a dedicated space. Create a zone specifically for products entering the facility, and then draw up another as an exit area for the end product going out. This is a concept known to bolster flow in a single direction. Consider where your employees will come in and out. This can help you further plan what your operation will look like as you walk through each step.
To be GMP compliant, waste must be removed from the facility, and its singular flow must be separate from the raw materials and finished product. The size of the rooms should be sizable enough to operate ergonomically and safely, but they also must remain small due to the high cost of air treatment by HVAC systems. In fact, about 70 – 80% of the electricity consumption will be in the HVAC system for most Pharmaceutical manufacturing facilities.
Step 2: Sizing Rooms for Production
Determining sizes for rooms is key to GMP-compliant production. To take a closer look at this, we must explore factors such as production capacity, the type of products to be manufactured, and process equipment, as size is key to determining room sizes. Inside the room, there must be enough space for pallets for moving materials, operators, and space around the process equipment to open doors and perform routine maintenance. The height production rooms should be created at a minimum of 3 meters (9 feet), but this can be increased depending on the size of your processing equipment. Keep in mind that room volume is proportional to your operation’s future electricity consumption. Before you begin this stage, create a list of all of the rooms you’re planning, as well as key features such as size estimates and necessary equipment for each room. This will serve to organize your process and act as a basis later to increase or decrease room sizes or number of rooms.
Step 3: Consider Production Flow
When it comes to design, fluidity promotes efficiency. Streamlining operations will ease the process from the beginning to the end of the production process. Start this process by drawing blueprints of rooms and considering how to move products from one room to another. For example, draw plans for rooms chronologically and base the plans on each step the product will make, each step employees will take throughout the facility, or alternatively begin with both.
In any case, the goal is to think about each room and how they relate to people and product movement. Think of the best ways to bring in raw materials, the pharmaceutical cannabis flower extraction process, purification, final pharmaceutical product considerations, primary and secondary packaging, and delivery to your clients.
Step 4: Locational Planning and Building
When planning out where your facility shall be built, be sure that it’s located in an area that doesn’t have many contaminants like dirty air or water. Avoid nearby Municipality Waste Water Treatment Plants that can bring microbiological contaminants into the air. Furthermore, access to the facility should be easy, and solid road construction should be the standard.
The height of the building is another important factor to consider. Normally above the cleanrooms, the technical area with Air Handling Units (AHU ) of the HVAC (Heating, Ventilation, and Air Condition) is built. So consider that above the cleanrooms, you may need at least 3 m extra height. Moreover, electric power levels must be checked to be sufficient, and the HVAC system must be equipped with a chiller that will provide cold water in a closed loop AC to the AHU to best control the temperature and the humidity inside the Cleanrooms. Proper air filtration is one of the most critical parts of cleaning areas and must be considered during the planning process.
Step 5: Site Master Plan
Develop a master plan with the position of this in a logical organization to minimize operational costs. List the main areas the Facility needs.
For example:
Outside
– Dock area for truck – Electricity Transformer
– Chiller – Wastewater Treatment Plant
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Inside
– Warehouse raw materials – Cleanrooms – Warehouse finish product – Expedition area – Quality Control Laboratory – Offices – Changing rooms
Step 6: Positioning Changing Rooms in the Layout
The position of personnel changing rooms may be reduced to minimal length of the corridors. Ideally all changing rooms should be together, but there must be separate access to the clean areas of the non-classified areas. The entrance and exit of the changing rooms is critical to avoid cross contamination. Normally, a bench is used so that all employees can sit, apply booties and cross to the other side of the clean area from the dirty area.
Step 7: Future Expansion of the Manufacturing Facility
Plan from the beginning to the end, and then plan expansion in the middle for each main area of the manufacturing facility. For example: warehouse, extraction, manufacturing, packaging, and laboratory.
Step 8: Safety and Security
As the saying goes, safety always comes first. Design the facility to have accessible exit paths and push bar doors opening in the direction of the exit. Ethanol detectors must also be installed and used to avoid operator intoxication or creation of an explosive atmosphere. To further increase safety, set up security cameras for general views of rooms and corridors. Of course, fire suppression systems must be planned to code.
Working in a narcotic-registered pharmaceutical manufacturing facility requires serious security.
In Pharmaceutical Cannabis, even more so. In the facility's design, have a security expert inspect and analyze your layout plans. Accordingly, prepare the facility to reduce the chances of employee theft. Diversion will cause a loss of your licensing.
Step 10: Pressure – Avoid Cross Contamination
Layouts must be configured in a way that cross-contamination can be adequately avoided and utilize different pressures between rooms and corridors. Normally a difference above 10 mPa is recommended. Air contaminants are always being cleaned by air handlers, but contaminants must be perfectly contained to reduce the spread of bacteria and pollutants.
Step 11: Hiring GMP Professionals
When you are designing the layout, ensure that you consult with a professional like a manufacturing manager or the technical director with experience in Industrial Pharmaceutical Plants. Once you’ve completed your design, send it to a clean room specialist for pharmaceutical GMP or an architect for food GMP.
Once your plans are set, have your GMP professional review the plans, like the technical director, as their relevant experience in Industrial Pharmaceutical Plants will help to get the project on the right path or submit your plans for review from a consultant company.
If you are patient and you move through the steps or modify the basic steps to suit your team or way of visualizing the project, you should feel confident to start construction. Each week work through drafts, and rethink room positions and sizes until you cannot find any changes anymore. By the end, you probably are only questioning small changes like door positions since all the major work was done in the initial stages.