GMP Series Part 2: Building and Design – Authored By:  Michael Sassano and Antonio Guedelha

GMP Series Part 2: Building and Design – Authored By:  Michael Sassano and Antonio Guedelha

    

GMP Series Part 2: Building and Design – Authored By:  Michael Sassano and Antonio Guedelha

Thankyou to our newest contributor Michael Sassano for his second article in his series  for us explaining GMP compliance.

If you are a North American company wishing to do business in the EU, UK , Australia & NZ you will need to be, above all, GMP compliant otherwise you won’t even get past “GO”. Never mind all the other compliance issues you’ll need to deal with !

Authored By:  Michael Sassano and Antonio Guedelha

Michael Sassano

 

In the quest to become GMP compliant, 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 product should be considered at every stage of designing your facility. The entire process should be created in such a way to avoid cross contamination and move product and people throughout
the facility as safely as possible.

Today, we continue our series on Good Manufacturing Practices; this time discussing what you need to know about building and design as well as 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 dedicated space. Create a zone specifically for product coming into 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 to further plan out what your operation will look like as you walk through each step.

In order 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 high cost for 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 of the room, there must be enough dedicated space for pallets for moving materials, space for 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 depending on the size of your processing equipment, this can be increased. 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 three: 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 product 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 thought 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 products considerations, primary and secondary packaging and delivery to your clients.

 

Step four: 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 a lot of contaminants like dirty air or water. Avoid nearby Municipality Waste Water Treatment Plants that can bring microbiological contaminants in 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 the 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

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,
laboratory.

Step 8: Safety and Security

As the saying goes, safety always comes first. Design the facility to have accessible exit paths and with push bar doors opening in the direction of 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 a narcotic registered pharmaceutical manufacturing facility requires serious security.

In Pharmaceutical Cannabis even more so. In the design of the facility, have a security expert inspect and analyze your layout plans. Accordingly, prepare the facility to reduce chances of employee theft. Diversion will cause loss of your licensing.

Step 10: Pressure – Avoid Cross Contamination

Layouts must be configured in the 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 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 on construction. Each week work through drafts, 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.

New

Cannabis Law Journal – Editorial Board Members

Editor – Sean Hocking

Author Bios

Canada
Matt Maurer – Minden Gross
Jeff Hergot – Wildboer Dellelce LLP

Costa Rica
Tim Morales – The Cannabis Industry Association Costa Rica

Nicaragua
Elvin Rodríguez Fabilena

USA

General
Julie Godard
Carl L Rowley -Thompson Coburn LLP

Arizona
Jerry Chesler – Chesler Consulting

California
Ian Stewart – Wilson Elser Moskowitz Edelman & Dicker LLP
Otis Felder – Wilson Elser Moskowitz Edelman & Dicker LLP
Lance Rogers – Greenspoon Marder – San Diego
Jessica McElfresh -McElfresh Law – San Diego
Tracy Gallegos – Partner – Fox Rothschild

Colorado
Adam Detsky – Knight Nicastro
Dave Rodman – Dave Rodman Law Group
Peter Fendel – CMR Real Estate Network
Nate Reed – CMR Real Estate Network

Florida
Matthew Ginder – Greenspoon Marder
David C. Kotler – Cohen Kotler

Illinois
William Bogot – Fox Rothschild

Massachusetts
Valerio Romano, Attorney – VGR Law Firm, PC

Nevada
Neal Gidvani – Snr Assoc: Greenspoon Marder
Phillip Silvestri – Snr Assoc: Greenspoon Marder

Tracy Gallegos – Associate Fox Rothschild

New Jersey

Matthew G. Miller – MG Miller Intellectual Property Law LLC
Daniel T. McKillop – Scarinci Hollenbeck, LLC

New York
Gregory J. Ryan, Esq. Tesser, Ryan & Rochman, LLP
Tim Nolen Tesser, Ryan & Rochman, LLP
Cadwalader, Wickersham & Taft LLP

Oregon
Paul Loney & Kristie Cromwell – Loney Law Group
William Stewart – Half Baked Labs

Pennsylvania
Andrew B. Sacks – Managing Partner Sacks Weston Diamond
William Roark – Principal Hamburg, Rubin, Mullin, Maxwell & Lupin
Joshua Horn – Partner Fox Rothschild

Washington DC
Teddy Eynon – Partner Fox Rothschild