Rapid Therapeutic Enters Contract for Certified Lab for Manufacturing Consistent with FDA Rules
DALLAS, June 30, 2020 (GLOBE NEWSWIRE) -- Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL) an SEC fully-reporting, growth-oriented company focused on manufacturing and marketing aerosol delivery systems based on pressurized Metered Dose Inhaler (MDI) technology, announced today that it has executed a contract leasing a new state-of-the-art laboratory. The laboratory is being certified for manufacturing under Food and Drug Administration (FDA) rules.
Rapid Therapeutic Science Laboratories, Inc. Chairman and CEO, Donal R. Schmidt, Jr. stated, “We are extremely pleased to announce the Company has leased a state-of-the-art lab tested to ISO 6 standards. This lab will allow us to immediately pursue RTSL’s stated goal of FDA registration of all RTSL products. RTSL will immediately begin manufacturing according to ISO 13485 standards for medical devices.” https://www.iso.org/iso-13485-medical-devices.html. https://www.iso.org/standard/59752.html. The FDA adopted this standard in 2018. https://www.iso.org/news/ref2318.html.
Sean Berrier, Sr. VP and Co-founder commented: “RTSL will not maintain the lab as a certified “clean room,” instead the Company maintains general facility/process controls in its environmentally filtered operations, as part of compliance with FDA Good Manufacturing Practices (GMP) related to ISO 13485. Nevertheless, RTSL will periodically perform random testing to assess initial set-up, filter functional efficacy, personnel gowning consistency, and general process stability. Under ISO 13485 the lab rooms will function as “control rooms.” The goal is to organize layout, and minimize overhead particulate matter, thereby optimizing process flow and reducing product fallout. This allows for RTSL to manufactue a class II medical device under GMP. We believe we are one of only a handful of companies manufacturing CBD consumer products with this level of sophistication. This lab gives our clients a high level of assurance that our products are safe and clean with no adulterations.”
About Rapid Therapeutic Science Laboratories, Inc. (OTC: RTSL)
RTSL is an aerosol manufacturer which has developed and perfected a new method of formulation and manufacturing to deliver pure CBD, CBG and/or THC and combinations thereof in legal jurisdictions to consumers through an FDA approved medical device known as a pressurized Metered Dose Inhaler (pMDI or MDI). The Rxoid MDI product line is manufactured in compliance with GMP on FDA approved equipment. Non-THC Cannabinoids are not yet approved by the FDA but are legal to consume in TX and many other states and export to legal foreign jurisdictions.
An MDI is a replacement for vape pens, as it uses no heat and needs no dangerous ingredients to work. In addition, MDIs are less expensive than any other route of delivery measured by blood serum levels. They are however expensive to formulate and manufacture so that they legally and properly work as an MDI under FTC rules on truth and labeling.
RTSL markets its Rxoid™ MDI products directly to pharmacies and physicians who treat GAD, PTSD and other stress and anxiety disorders.
RTSL’s MDI products also can be purchased by consumers online at www.rxoid.com.
We encourage all customers to do their own research regarding cannabinoids, the use of MDIs and our products. RTSL makes no claims about therapeutic benefits of its products. None of our products are intended to diagnose, treat, cure or prevent any disease. Always consult a physician prior to using any cannabinoid product. If you experience any adverse reaction stop use immediately and seek appropriate medical attention. RTSL’s products are not approved by the FDA or under the Food Drug & Cosmetics Act (FD&C Act).
Visit our corporate website at www.rtslco.com.
Source: Rapid Therapeutic Science Laboratories, Inc.
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