Manufacturing Non-sterile Products Intended For Use In Healthcare Settings

Manufacturing Non-sterile Products Intended For Use In Healthcare Settings

  JOHN MISOCK

  Senior Consultant

Ceutical Labs

  When : Tuesday, November 16, 2021

  Time : 02 : 00 PM EST

  Duration : 60 Minutes

  Product ID : MISO-0016

  Level : Advance

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John is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from the FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.

John Grew up on a farm in Ohio where he learned a great deal about self-reliance, resilience, and creativity. Leaving the farm to start his journey, John graduated from Ohio State University and the University of Wyoming. The skills that John learned in those early years bring him to you today. If you have a chance, ask John about his experience as a shepherd in Wyoming’s Big Horn Mountains. John is also a musician and vocalist, something he has enjoyed since performing professionally at age 16.

Cosmetics and OTC products that are intended for use in healthcare settings are being used by individuals that are vulnerable to opportunistic pathogens. Products including lotions, creams, toothpaste, mouthwash and mouth moisturizers are commonly given to patients for their personal use while in the hospital. Other products like surgical preparations and shared hand creams for workers can become contaminated if not manufactured adequately. Both Gram negative and Gram positive bacteria as well as fungi can become pathogenic in these situations. Manufacturing methodology that is adequate for products used by the general population may not be adequate to prevent contamination that could cause serous illness or death for people, including infants, who use these products in a healthcare setting. Product formulations that do not represent a higher risk to healthy people need extra attention to assure their safety when they are intended for use in healthcare settings. Micro standards that apply to products intended for general populations do not assure a level of safety necessary to protect vulnerable populations. Learn key factors necessary to assure your products do not pose unnecessary risks to vulnerable populations. The current lab methods you use may not detect pathogens that can be deadly to vulnerable populations. Learn what aspects of testing most laboratories overlook that could make the difference between releasing contaminated product and assuring that your products are safe for all who use them. Keeping water systems in compliance by following commonly accepted practices may not be adequate to assure that your products are safe for use by vulnerable populations. What are the causes of contamination in cold processed products and how can I correct problems? What are the pathogens of concern in my product? Should my product by sterile? Does my sampling and testing regime detect all pathogens of concern? Do you know and control the organisms commonly found in your plant environment and raw materials? Is your manufacturing equipment and processes a source of contamination? What aspects of cleaning and sanitization can contribute to contamination? In recent years there has been a shift away from well known and stalwart preservative systems that are capable of controlling growth of a wide variety of microorganisms under a broad range of formulations. The demand for natural alternatives to traditional preservatives makes the job of preserving products a magnitude of difficulty greater. Classic approaches to preservative efficacy testing may not detect contaminants that cause adulteration of your products. Corresponding to this new reality, the necessity to conduct robust stability tests on your products is much more important than in the past. Should products intended for vulnerable populations be sterile? Or, is there another level of safety that can be applied to assure the safety of these products? Many factors can contribute to contamination that demand attention to improve the safety of your products. I addition to causing injury to your vulnerable customers, failure to put adequate controls in place may put you in cross hairs with FDA. You can unwittingly become a party to a recall when your products are implicated by a distributor or retailer long after a product leaves your facility.

Areas Covered

  • What are healthcare products?
  • Opportunistic pathogens
  • Determining levels of pathogens in raw materials and the environment
  • Preventing manufacturing contamination
  • Critical control points
  • Product formulations
  • Microbiological evaluation to detect opportunistic pathogens
  • Causes of contamination in cold processed products
  • Pathogens of concern
  • Sampling and testing to detect all pathogens of concern
  • Controlling house organisms
  • Sources of contamination in manufacturing equipment and processes
  • Cleaning and sanitization practices – bad, good and the best
  • Natural preservative systems - making the change
  • Preservative efficacy for high risk products
  • Stability testing for healthcare products
  • Adequate level of safety – sterility or something else?
  • FDA inspections, warning letters and recalls

Course Level - Intermediate & Advanced

Who Should Attend

Senior leadership and Directors, Managers and Supervisors

Why Should You Attend

If you manufacture cosmetics and OTC products that are intended for use in healthcare settings your products are being used by individuals that are at higher risk of being injured by pathogens then the general population. Product formulations that do not represent a higher risk to healthy people need extra attention to assure their safety when they are intended for use in healthcare settings. Meeting micro standards that apply to products intended for general populations do not assure a level of safety necessary to protect vulnerable populations. Learn key factors necessary to assure your products do not pose unnecessary risks to vulnerable populations. Keeping water systems in compliance by following commonly accepted practices may not be adequate to assure that your products are safe for use by vulnerable populations. The current lab methods you use may not be adequate to detect pathogens that can be deadly to vulnerable populations. Learn what aspects of testing most laboratories overlook that could make the difference between releasing contaminated product and assuring that your products are safe for all who use them.

Topic Background

Cosmetic and OTC products used in healthcare settings have been associated with serious outbreaks in hospital ICU’s and other healthcare settings. These products are often parts of an amenities kit used by vulnerable populations. The presence of pathogens in these products can cause serious and life-threatening adverse effects for users, that may be immune compromised due to a disease state or injury.

  • $179.00


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