Continuous Manufacturing Solutions

extraktLAB’s continuous manufacturing solutions provide a continuous closed loop solution for several endpoint needs.

continuous manufacturing automation

Top GMP Reasons to Automate

  • Eliminate thousands of cumulative quality checkpoints and hundreds of thousands of pieces of paperwork.
  • Seriously reduce validation efforts by validating a single process rather than five processes.
  • Elimination of cost and validation of ethanol.
  • Containment systems and automation produce best patient outcome.
  • No chemical residuals.
  • Eliminate risk of external contamination.
  • Pipe directly from automation to automation.
  • Formulation containment vessels for much less infrastructure cost.
continuous manufacturing automation

Top GMP Reasons to Automate

  • Eliminate thousands of cumulative quality checkpoints and hundreds of thousands of pieces of paperwork.
  • Seriously reduce validation efforts by validating a single process rather than five processes.
  • Elimination of cost and validation of ethanol.
  • Containment systems and automation produce best patient outcome.
  • No chemical residuals.
  • Eliminate risk of external contamination.
  • Pipe directly from automation to automation.
  • Formulation containment vessels for much less infrastructure cost.
winterized oil

Extraction through Winterization

Learn more on how to automate your process from extraction through producing winterized oil.

distillate oil

Extraction through Distillation

Learn more on how to automate your process from extraction through producing distillate oil.

crystal isolate powder

Extraction through Isolation

Learn more about the extraction through crystal isolate production process.

chromatography eluent

Extraction through Chromatography

Automate your process from extraction through chromatography separations.

FEATURES
Streamlined Extraction Process
NO Winterization
NO Ethanol

BENEFITS
Faster Production
No Mess, Less Contact, Less Potential for Loss
Better Yield

VALUES
Reduced Cycle Time
Reduced Labor Costs

Calculate the savings in just one of these automations: extraction through distillation. Just imagine if you were to automate from extraction through winterization, extraction through isolation, and/or extraction through chromatography.

Our continuous manufacturing automation solutions are designed to be used independently or together for a fully automated process.

Frequently Asked Questions

What is cGMP & EUGMP?

Current Good Manufacturing Practices, or cGMP, is a set of standards defined by the FDA that are intended to ensure acceptable manufacturing processes in regulated industries like pharmaceuticals, food and supplement manufacturing.

These standards can apply to: assurance of raw material quality, testing parameters, standard operating procedures, quality management, identifying and investigating deviations, etc. All of these standards intended to mitigate potential risks of contamination, quality failure or any other impact to potential customer safety.

Essentially the same principle, EUGMP standards are set instead by the European Medicines Agency intended to ensure quality and safety of products in the food and pharmaceutical industries.

What Are the Differences Between EUGMP & CGMP?

Though similar, there are a few key differences between cGPM and EUGMP. In both instances, a yearly review of manufacturing practices and product quality is required.

The FDA “Annual Product Review” (APR) is implemented to evaluate the quality standards of each drug product annually and also determines the necessary changes in specifications and operating procedures.

The primary task of the EU ”Product Quality Review” (PQR), however, is to focus primarily on the overall quality and manufacturing system and to show that any manufacturer is consistent in quality control when creating their products.

Why do cGMP and EUGMP Regulations Matter?

From producer to customer, these GMP standards are essential to ensure quality and consumer safety. Without these standards, it would be all too easy for manufacturers to cut or compromise quality practices that are implemented for the end user to receive a good, safe product.

This applies to risk of contamination, mistakes like mislabeling, consistent product contents, etc. Not only could this lead to a product that may be unsafe, it could lead to a product that is essentially ineffective.

Unless you intend to keep your market in your own country, it is important for you to pay attention to (and abide by) both cGMP and EUGMP standards. The CBD industry is often referred to as the wild west because of its rapid legalization without the standardization to match. While that research is being conducted, producers can confidently create a product that is safe and effective for their customers by adhering to these GMP guidelines.

Is This a Federal Law or State Law? Do States Force You To Use it?

Any manufacturer of food or active substances is required by law to adhere to GMP standards.

In the United States, GMP standards are enforced by the FDA. This can be monitored through regular facility inspections that ensure a manufacturer is complying with cGMP standards during production.

Serious violations of those standards, can result in product recall or other serious repercussions that could severely impact the manufacturer in terms of profit loss and operations.

If You are Based in the US and Want to Sell Hemp Products to the EU do You have to be EUGMP Certified?

Yes. While similar, your facility will need certification in both US and EUGMP standards in order to sell any hemp based products from the United States to Europe.

This can be advantageous overall when entering the markets of other countries as the standards of EUGMP are notably high. This allows for the potential access of a multinational European CBD market as opposed to a singularly American market.

Meet Our CEO and Founder Dr. Jon Thompson, Ph.D

profile-jon

Dr. Thompson is a separations scientist, entrepreneur, and inventor. As a scientist, he has a strong technical background and industry experience in analytical instrumentation, in-vitro diagnostics, biotech, mining, and homeland security markets. During his industry career, Dr. Thompson has earned a strong track record of winning and implementing botanical extractions, formulations, quality, and products in well-regulated, medically-modeled states.  Dr. Thompson has assisted numerous companies to attain their goals in hemp manufacturing, as well as market development, strategic marketing, and worldwide business-to-business alliance formation (including international markets).

 

He received a Bachelor of Science degree in Biochemistry, Master of Science degree in Chemistry and a Doctor of Chemistry degree–all from the University of Minnesota.

Get in touch with our team to request a quote, learn more about our training or get help with your business plan.

We are dedicated to providing you with the best advice, quality and service in the industry.

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No Ethanol, No Winterization,

No kidding!

Extraction through Distillation

Automation System.