GMP During Covid-19

Vitalis GMP During COVID-19

 

THE FUTURE OF MANUFACTURING

In the global race to combat the pandemic with medical supplies and vaccines, the role that manufacturing plays has never been more important. While the pace of production is where minds may go first, what’s proving to be an invaluable lesson in times like these regardless of industry, is ensuring operations meet levels of regulatory compliance, quality assurance, and safety.

Governments around the world are leaning heavily on manufacturers who have the capacity or the ability to pivot their operations to produce critical medical supplies from personal protective equipment (PPE) to ventilators and testing kits - and the inevitable pharmaceutical race to produce a vaccine. The common theme in the manufacturing of these items is that they must meet Good Manufacturing Practices (GMP) to ensure the products are safe, effective and of high quality. While the time factor is certainly crucial, deviating from GMP standards and practices could mean the creation of defective products, and unsuccessful attempts to deliver life-saving support.

 

FDA Regulation & GMP Compliance

Even for the most unsuspecting of industries and companies, especially those in the cannabis space, what we are facing today, is a reminder that preparing for the future is not only smart, it’s good business practice. With cannabis classified as an essential service, we’ve seen a knock-on-effect of an increase in the distribution of licenses, including those in the pharmaceutical and consumable spaces. Edibles and topicals are the fastest-growing segment of the cannabis market - U.S. retail sales of cannabis and CBD products reached $14 billion in 2019, and are on pace to increase 18% a year to $33 billion by 2024, according to data published in “Cannabis and CBD: U.S. Retail Market Trends and Opportunities,” by market research firm Packaged Facts. 

The new trend in cannabis production has dictated that when it comes to producing products bound for human consumption, it isn’t about getting there first, it’s about getting it right. The FDA is close to implementing new standards for regulation of cannabis-infused products, especially within the CBD markets to patrol any misleading health claims. What’s important for cannabis producers in the USA to know is that while you can’t get FDA GMP certification currently, there are steps you can take now in structuring your businesses to be FDA compliant in preparation for new regulations coming in the future.

The billion-dollar cannabis industry is growing, even in economic periods of uncertainty like these, which means planning for the future has to start today. Gaining or at the very least preparing for GMP accreditation is not only a step towards accessing new cannabis markets, but it’s just as important to improving brand reputation. When consumers see a GMP-labelled cannabis package, they know the product is safe, high quality, and effective. GMP accreditation also fosters trust with supply chain partners (as can be seen in the recent COVID-19 manufacturing partnerships), which saves time and money in securing deals when new opportunities present themselves.

 

GMP Equipment Qualification

How exactly do you achieve GMP? GMP covers all aspects of a manufacturing operation, so it's important that your suppliers can support your GMP requirements, from raw materials and facility design, to equipment and packaging. And when it comes to your extraction machine - scrutiny for qualification is placed on the way it was fabricated, built, and tested, as well as commissioned. Extraction equipment must be designed and constructed in a way that is streamlined, safe, and reliable, reducing chances of contamination, and be able to withstand repeated use and cleaning.

How a manufacturer meets GMP regulations is entirely up to them as GMP regulations have been structured to allow such flexibility. While it is the responsibility of every cannabis product manufacturer to bring their production facilities into compliance with GMP regulations, it’s definitely not a journey that one should embark on alone. Given the massive scope and highly technical nature of GMP across every area of business operations, it’s vital to get the help of an experienced consultant or expert early to assist with the design, planning, qualification, validation, and manufacturing processes.

As experts on the design and construction of our equipment, our team of GMP experts are there to reassure customers that Vitalis equipment can be qualified within their GMP environment by walking them through a 5-step process towards achieving GMP Qualification.

As an international GMP-compliant equipment supplier to the pharmaceutical and recreational cannabis industries, Vitalis specialists not only have a deep understanding of not only Canada's Good Production Practices (GPP), but GMP regulations around the world and will ensure that the qualification of the Vitalis equipment goes smoothly. To join our list of customers enjoying successful GMP operations, reach out today.

 

 

Buying Tips: Not All Machines Are Created Equal

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SAVE TIME, EFFORT AND STRESS WITH THESE CONSIDERATIONS

When looking at extraction equipment, there are a lot of things to keep in mind. Price, reliability, safety and performance are top criteria that come readily to mind. For any business owner, procurement manager or buyer, the key goal is to ensure that they get a good deal on a system that will meet the company needs. To ensure a positive experience, and an efficient decision-making process, Careful consideration of the following factors will help keep your extraction system evaluation(s) on track for a successful purchase..

KNOW YOUR END GOAL

When you're looking for CO2 extraction equipment, the first thought should be to your end goals. What do you want to produce? Different market products call for different pathways to production, including with regards to equipment requirements. For example, will you need to perform extractions in both subcritical and supercritical states in order to extract the target compounds for your products? Will you need to pull every ounce of recoverable material out of the biomass or will your profit curve require you to end an extraction run early? Will your system need to have precise control over the extraction parameters or are you comfortable spending more time on post-processing? Understanding the end product you want to produce will allow you to trace back through the process, identify the appropriate extraction equipment, and make informed decisions based on profit margins, resource requirements, and time.

BE CLEAR ON CAPACITY NEEDS

If your extraction plans require you to process thousands of pounds of biomass a week, you'll need to look at systems that have the capacity to meet those requirements. Small-volume systems, or systems requiring longer run times can make it hard to reach large volume goals. Understanding the volume of feedstock you'll be working with is a huge factor in making a smart decision on extraction equipment. It can also help you identify other revenue opportunities. For example, if your volume needs are small, perhaps it makes business sense to do toll-processing, making a profit by processing another supplier’s biomass.

AVOID OUTRAGEOUS CLAIMS

A savvy shopper knows the importance of investing time in understanding a process or product before making a purchase. Marketing strategies in the extraction environment are often flooded with outrageous claims. It is important to understand the science underlying the process of extraction and that, regardless of equipment type or manufacturer, no piece of machinery can operate outside of physical laws. Time spent studying the fundamental principles of how temperature, pressure, time and flowrate factor into extraction will pay dividends in vetting sensational schemes and decoding fine print.

YIELDS VS RECOVERY VS EFFICIENCY

Yields is an entire topic on its own and comes up quite frequently in conversation about extraction equipment. Most often, it is used as a simple measure for buyers to evaluate the efficiency of a system. However, using yields as a measure of extraction efficiency is akin to using horsepower to evaluate the speed of a vehicle - a semi-truck can have excessive horsepower, but that doesn't necessarily mean it will go fast. Bulk yield is a measure of the total mass of material that results from an extraction, but it doesn't provide a clear picture of the amount of valuable material recovered. Understanding recovery percentage and knowing the chemical composition of the biomass can help eliminate confusion on the topic of yields and prevent decision-making based on erroneous criteria (for a better understanding of Yields, read this article).

LICENSING & FACILITY

Licensing and regulations can vary dramatically between nation, state, city and even county lines . The products that can be processed, the size and engineering requirements of the facilities, and the type and amount of chemicals allowed on-site are all major factors to consider before going too far on your extraction system purchase. But more than just the regulatory landscape, the simplest reason to consider your facility and lab setup before buying equipment is to ensure that you'll be able to get it into the room. It's rather difficult (impossible) to move a five-foot-wide piece of equipment down a four-foot-wide hallway, and putting a ten-foot-tall system in an eight-foot-tall room can be a daunting (also impossible) task. Knowing your building dimensions and size requirements can save from excessive retrofitting costs down the line.

SCALING & COSTS

Having clarity on desired growth, sustainability, and a solid plan in place are also key factors to consider when choosing extraction equipment. While these are certainly true of any business venture, they should be included within this decision-making process. If your goal is to scale and grow, purchasing equipment that can do the same is a smart idea. By the same token, obtaining a system that will require multiple installations in order to scale can be costly and negatively impact your overall efficiency.

As well as examining your growth potential, understanding the difference between capital expenditures (CapEx) and operating expenditures (OpEx) is important when looking at long term strategies. In some cases, higher CapEx can lead to much lower OpEx in the long run, creating a positive ROI in a shorter amount of time. Without thoroughly examining the options, it can be easy to go with a lower upfront cost despite the fact that it can be detrimental to growth in the long run. Being clear on your finances and estimated return from the start, you can save yourself from stress and unnecessary expenditures in the future.

Often in the buying process, it's easy t get blinded by low-cost options and empty promises. Negotiations over cost and delivery have become a natural part of the process. Of course, there are many more factors to consider when making a significant purchase, as is the case when evaluating CO2 extraction equipment. By keeping the above tips in mind, you will be better prepared to make a sensible decision that can set the stage for your company's future success.

If you're looking at making an investment in CO2 extraction equipment and are unsure where to start, these tips are a great spot. For further help and assistance, reach out to our Business Development team to get the conversation started. They'll help identify an equipment solution to perfectly fit your short-term and long-term goals.

GMP Overview Part 1: What is GMP?

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In an effort to ensure medical cannabis products are safe for consumers, many countries around the world are adopting Good Manufacturing Practice (GMP). GMP certification ensures creation of safe and effective medical cannabis products that are held to the highest manufacturing standards, much like traditional pharmaceutical products. As countries move to regulate medical cannabis products under the GMP umbrella, cannabis producers, manufacturers, and suppliers are having to understand and implement GMP in their businesses.

This article is the first part of a three-part series looking at what GMP is and its importance, the costs and benefits of GMP compliance, and the areas of the GMP process an equipment vendor can play a central role in.

With GMP becoming more significant in the cannabis industry, what is GMP?

GMP is a series of regulations that are enforceable by law, used to ensure products are consistently created in such a way as to meet rigorous quality standards. Typically, the agencies responsible for issuing GMP regulations are also responsible for enforcement. These regulations provide minimum requirements that a manufacturer must observe to ensure all products are safe, fit for the intended purpose, of high quality, and of consistent formulation or construction.

The regulations cover product categories including pharmaceuticals, food and beverages, dietary supplements and medical devices. GMP also covers all aspects of production from the raw materials, facilities, and equipment to the training and even personal hygiene of staff. This reinforces the primary goal of GMP: to prevent harm to end users of a product.

GMP regulations are not rigid instructions on how to manufacture products and structure processes. Such strict regulations would not only be impractical to translate across numerous industries, but it would also remove the motivation for manufacturers to innovate and adopt new technologies and methodologies. Instead, the requirements were established to be flexible, allowing manufacturers to determine the best way to implement scientifically sound design, processing systems, and testing procedures.

This flexibility allows adoption of the most up-to-date technology and methods, as well as letting companies decide the best way to implement the controls necessary to achieve the highest quality within their organizations. When manufacturing processes and quality systems are set up by a manufacturer, there may be many ways in which they can fulfill GMP requirements. The responsibility is on the manufacturer to determine the most effective and efficient quality process that meets both business and regulatory needs.

Is GMP always the same everywhere?

GMP guidelines and interpretations differ between both countries and regions, and even over time. Due to this consistent change, the most recent iterations are often referred to as Current Good Manufacturing Practice (cGMP). This system ensures that manufacturers use the most current systems and technology, as cutting-edge practices of 20 years ago may no longer be acceptable by current standards.

Why is GMP important?

First and foremost, GMP is for consumer safety. A consumer of medical cannabis products needs to trust the efficacy and quality of the products they are prescribed. Having checks and balances through GMP regulations gives manufacturers the ability to pick up on quality defects early and ensure unsafe products are not released to the public. There have been many documented cases where quality processes were not followed, and defective products were released. This highlights the importance of GMP regulations and the critical role they play in consumer safety.

For the businesses involved directly with medical cannabis, there are some distinct advantages of adopting GMP. Many authorities around the world, including the USA, Canada, Australia, Japan and the European Union (EU), require the application of GMP in the production of drugs, food, and cosmetics that will be sold in their respective markets. GMP certification will allow access to more markets. While GMP is not enforced in every country where cannabis cultivation is legal, it appears that GMP will become the norm for medical cannabis products and potentially for recreational products in the future. Thus, although GMP enforcement may not be required, lack of compliance could become a reason for restricted access to some markets and/or loss of sales.

Want to know more?

Register today for our GMP Webinar

June 18, 2019 11AM Pacific / 2PM Eastern

Press Release – October 2, 2018

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Canada’s First ASME Certified Extraction Equipment Manufacturer

Vitalis Extraction Technology Raises Bar, Sets New Standard in Growing Cannabis Industry

KELOWNA, BRITISH COLUMBIA,CANADA , October 2, 2018
Vitalis Extraction Technology, the largest supercritical CO2 extraction equipment manufacturer serving the international cannabis industry, today claimed the title as Canada’s first and only American Society of Mechanical Engineers (ASME) BPV certified extraction original equipment manufacturer (OEM) in the cannabis industry. The announcement comes on the heels of the company’s rapid expansion that doubled its production capacity.

While all Vitalis Extraction Technology equipment has always been designed, fabricated, and tested and certified in accordance with the latest ASME and CSA codes, the recent ASME certification now allows Vitalis to manufacture its own certified pressure vessels in-house, owning the process from start to finish.

“Becoming ASME certified to manufacture fully-certified vessels in house was a huge undertaking and an even bigger accomplishment,” said Pete Patterson, COO and co-founder of Vitalis Extraction Technology. “ASME completed an extensive audit of our fabrication facility and processes and found our methods and procedures to be excellent. Being able to produce certified vessels in house is unprecedented in our nation’s industry. Reaching this goal was a true team effort that involved everyone from our founders to engineers and fabricators who all knew what it would take to keep us ahead in this competitive and growing market.”

Founded in 2016, Vitalis Extraction Technology produces the most sophisticated high-flowing, industrial-scale, supercritical CO2 extraction systems for the cannabis industry. Renowned for their reliability, scalability, and continuous operation, all Vitalis systems are designed and manufactured in accordance with ASME and CSA Standards for Boiler, Pressure Vessel and Pressure Piping Construction. Each vessel is stamped with a CRN and NB registration number confirming that the vessels meet both US and Canadian code requirements.

“Simply being ‘designed-to-code’ isn’t enough when you’re handling a high-pressure system,” said Joel Sherlock, chairman and co-founder of Vitalis Extraction Technology. “Extraction systems are a required component in cannabis oil production. With something so imperative yet potentially dangerous, safety is critical. Owning this process allows us to continue to build certified, ‘future-proof’ machines, designed to expand for increased output and volume as a customer’s demands increase.”

With full legalization on the horizon, tightened regulations are inevitable. Vitalis' ASME certificate affirms that each system is built in accordance with the latest regulatory codes, eliminating downstream problems for customers by helping to ensure compliance with their local jurisdictional requirements for installation and operation. Voted Top Extraction Equipment at the 2017 Lift Canadian Cannabis Awards, Vitalis is on the forefront of emerging Canadian and global markets. On track for a 105% increase in sales this fiscal year, these accomplishments confirm Vitalis’ place as the largest commercial supercritical CO2 extraction equipment company in the cannabis space in North America.

PRESS CONTACT

For Additional Information, please contact

Judy Campbell, Campbell Consulting
judy@campbellconsulting.com, 541-410-9113

The Importance of Certification for Pressure Vessels

Air tank with pressure gauge.

Do you work in an industry where the use of pressure vessels is common?

Then, explosions may be something you worry about. You want to stay safe at work and go home at the end of the day in one piece. Have you ever looked at a vessel and wondered how it can keep its pressurized contents safely in place? Who makes sure that these vessels are safe? Have you ever noticed the stamp or plate on a vessel and wondered what it means?

Let's find out!

What are Pressure Vessels?

If you don't work in a field that routinely uses pressure vessels, you may not know what they are. Simply put, they are containers that hold pressurized contents.

This means that the container holds its contents, either a gas or a liquid, at a different pressure than the atmosphere. It is critical that this vessel maintains its seal. Otherwise, the sudden pressure change will cause an explosion.

The vessels were originally invented to handle the steam needed to operate a steam engine back in the day. But now these vessels are very useful for a variety of applications. Everything on the following list uses these vessels in some manner:

  • Recompression chambers
  • Mining operations
  • Nuclear reactor vessels
  • Distillation towers
  • Submarines
  • Spaceship habitats
  • Petrochemical plants
  • CO2 extraction systems

These vessels are also routinely used for storing liquefied gases like propane, butane, LPG, chlorine, or ammonia.

Safety

As you can imagine, safety is a huge concern with these vessels. If you've ever popped a balloon with a pin, you have an idea of what would happen if a pressure vessel suddenly lost its seal.

Safety is the number one reason why proper certification is so important. The American Society of Mechanical Engineers (ASME) put into place their rather stringent standards in 1914. Before this, working with these vessels was very dangerous.

The vessels often failed and exploded. These explosions often severely injured or even killed anyone that was nearby. Obviously, this was not ideal. So the ASME put into place inspections and certifications that these vessels had to pass.

It didn't start out this big, but now the ASME's code encompasses 28 books and over 14,000 pages. It covers residential and industrial boilers and every pressure vessel imaginable.

It is an international code that everyone should adhere to. After all, it doesn't matter where you are on the planet. Physics is still physics, and a vessel will still explode under the same miserable conditions.

ASME Certification

Not all these vessels are created equally. They can handle a wide range of PSI. Thus the ASME construction code has different standards that apply to the vessels. Regardless, though, any vessel that will handle more than 15 PSI is subject to the ASME code.

The vessels are divided into three groups. Those that handle up to 3,000 PSI, up to 10,000 PSI, and those that handle pressures over 10,000 PSI.

The ASME has guidelines for the types of materials that can be used to build these vessels. Some requirements apply to all vessels. Others only apply according to how much pressure the vessel will handle.

Once the vessel has been approved, it gets a stamp or plate that boasts ASME certification. Many insurance companies will only cover a company that uses pressure vessels if every vessel has this ASME certification.

Of course, it's possible that any pressure vessel can fail. Don't assume that a vessel is foolproof just because it has been certified. But, meeting the certification standards greatly reduces the risk of failure and a potentially serious tragedy.

Good Design

In addition to the materials that can be used, the code also covers how the vessel should be designed. The ASME clearly lays out design standards that a vessel must meet or exceed to get certification. Even the shape of the vessel is essential for proper construction.

This also extends to the fabrication process. Manufacturers should follow certain procedures during fabrication that will help ensure the integrity of the vessel. Manufacturers must also follow a quality control regimen to ensure that the vessels they produce are solid.

The ASME also keeps an eye on the manufacturer's track record. The vessels that a manufacturer produces must consistently meet the ASME standards.

Transportation

While a pressure vessel can explode at any time, they are particularly dangerous during transport. The vibrations and jostling about that happen during transport can be just enough to cause the vessel to fail.

Imagine the devastation if a vessel explodes on a public roadway.

For this reason, the Department of Transportation also gets involved here. They issue an R-stamp that is very important. If a vessel needs repairs, the welder must have this R-stamp certification.

The welder (and the shop) have to undergo strict testing to receive this certification. Once they obtain it, they have to stay in good standing with the National Board of Boiler and Pressure Vessel Inspectors.

Improper repair of these vessels is a hazard to the public that is taken very seriously. This certification ensures that everybody stays safe.

Stay Safe

Who knows how many lives have been saved because of the ASME standards. But the only way to ensure that they keep saving lives is by following them.

Now that you know what ASME certification is and why it's so important, it helps to ensure that your vessels meet all the codes and standards. If you see a pressure vessel in use that doesn't have the proper certification, say something. You could potentially save someone's life.

Would you like to learn more interesting tidbits about chemical or mechanical engineering? Be sure to check out our education page. We've got great bits of interesting information about the exciting world of engineering.

INFOGRAPHIC | The Dangers of Butane

Stay Safe when you're extracting

Each week, more and more of these explosions make the news. Take a look at some real headlines from the past couple months alone.

Despite being an effective solvent for cannabis, butane is flammable and dangerous. Countless individuals are severely injured every month due to butane extraction labs, often located in densely-populated residential areas.

 

Butane Explosions

INFOGRAPHIC | Safety First – Does Your Pressure Equipment Have This?

Worried about your pressure equipment?

Certified equipment is vital to the continued success of your business.

Take a look at our infographic to learn about some of the certifications required to stay compliant and operational.

Certifications