Medicinal Cannabis Lean Manufacturing Design
The top consideration for any pharma or device Lean Manufacturing Design is the sheer size of some facilities and the wasted time gowning, for example, an operator has forgotten something on the other side of the personal airlock is just plain wasteful.
The manufacturing process of health care products involves hygienic practices. It is important that Lean Manufacturing thinking is considered in your facility design. We have all heard of the 7 wastes but increasingly we are seeing the 8th Waste has been added – Skill, or the lack thereof.
The success of your manufacturing facility is highly dependent on your design team’s skill.
Make sure your design is specifically targeted for success — especially efficiency and GMP compliance. If your facility has a sub-optimal layout, the skill of your operational team can never close that cultivation and production gap.
Over the years, and with my failing memory, I have learned that I need an easy way to remember the “wastes”, especially when examining a sub-optimal design, I spell out TIM WOODS –
T : Transport – Moving people, materials and even empty vehicles
I : Inventory – Storing work in progress, workpieces, documentation ahead of requirements
M : Motion – Walking, bending, lifting, turning, reaching
W – Waiting – manufacturing instructions, equipment or raw materials
O – Over-production – Making more than is IMMEDIATELY needed
O – Over-processing – Tighter tolerances or higher-grade materials than are necessary
D – Defects – Rework, scrap, incorrect documentation
S – Skills – Under utilizing capabilities, delegating tasks to staff with inadequate training
Typical Pharma Plant Design
Often pharmaceutical GMPs and Lean objectives are counter-intuitive, take for example a very basic requirement of unidirectional flow for a factory (low-risk products), the classic textbook design is to have the raw materials entering the facility on the left (as in the case below) and leaving on the right-hand side.
It is critical to design the facility correctly from the outset. Often, rubbing out of a line at the concept stage can be 1000x cheaper than trying to do so at the final project stages.
The GMP compliant design
The problem with this “GMP compliant design” is that as the sales demand is high and capacity is limited, there is temporary reduction through a product mix change or a machine break down, there could be increased stock sitting in the green raw material and the finished goods warehouse is empty. Shifting materials around is a waste.
One way to overcome this problem is to have a U-shaped plant design, this means awnings, dock levelers, road access and traffic flow is usually safer for your staff, i.e., their paths do not cross.
U Shaped Plant Design | Lean Manufacturing
In this example, you can see that the raw materials and finished goods share a common site access point, ramps, doors and dock levelers. But most importantly, the raw material and finished goods spaces can be expanded or contracted to suit real world changes.
Obviously, returns, rejected and labels need to be securely stored.
Increasingly, we are seeing Lean Manufacturing principles being applied to Pharmaceutical plants and Pharmacies
But there needs to be a sensible balance to ensure compliance and a sound understanding of both. Hopefully, this “almost” oversimplified example will encourage you to get a professional design, using PharmOut’s architects, engineers and GMP compliance experts as well as modern BIM tools. If not, at least request an independent design review by PharmOut’s Architects and Engineers i.e. design experts, before you start pouring concrete on your next project.
It could save you making a costly, unfixable mistake.
We see an additional advantage of a U-shaped design for a well-designed facility as now you have only a single-entry point and often a single vault. The back half of the facility is protected by at least two layers of security as per the Office of Drug control requirements for Goods of High Illicit Value or schedule 8 or 9 drugs.
PharmOut’s consultants can assist you with your TGA / EU GMP and poison licensing applications, processing and regulatory requirements.
Our pharmaceutical facility design architects, cleanroom validation, testing and processing engineers are experts in assisting manufacturers with environmentally minded designs for efficiency and GMP compliance. Contact PharmOut with your enquiry.
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