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802, 2016

E-Juice/E-Liquid Product Testing Analysis & Safety Information

February 8th, 2016|Blog|

eliquid and ejuice testing

Over the course of the past 2 years consumer demand for e-liquids and e-cigarettes has been on the rise. During this time period there has been many concerns from the general public about how safe these e-liquids are and what ingredients they are comprised of.

Common ingredients in e-cigarettes and e-liquids include nicotine, vegetable glycerin, propylene glycol, water, natural and artificial flavoring. Flavoring either natural or artificial is commonly used in e-liquids to represent a food or specific flavor such as traditional tobacco, honey, cereal, mint, and more.

Nicotine-containing liquid restrictions:
• EC must not contain more than 20 mg/ml of nicotine
• nicotine-containing liquid must be in dedicated refill containers not exceeding 10ml volume, and cartridges or tanks do not exceed a volume of 2ml
• additives are not prohibited but the nicotine-containing liquids cannot contain additives that are otherwise prohibited by the other Articles in the TPD
• high purity ingredients must be used and substances other than those declared should only be present in trace quantities which are unavoidable during manufacture
• ingredients must not pose a risk to health either when heated or not heated
• nicotine doses must be delivered at consistent levels under normal conditions of use
• products are required to be child and tamper proof, protected against breakage and leakage and have a mechanism that ensures refilling without leakage

Products must include a leaflet with information on:
• instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers
• contra-indications
• warnings for specific groups
• possible adverse effects
• addictiveness and toxicity
• possible allergy information

Current E-Liquid Safety Concerns:
The primary purpose of our analysis on e-liquid is for safety concerns and public health. Manufacturers and distributors of e-liquids (or e-juice) should be aware of what is in their product. Many safety concerns about contents of e-liquids have been constructed (and some fabricated). You should know what you’re selling to your customers.

Indoor Air Quality
Many studies have been performed for indoor air quality of e-cigarette vapor. A main question and voiced concern for the public is how second-hand vapor affects us. Please see the information below:

Comparison of the Effects of E-cigarette Vapor and Cigarette Smoke on Indoor Air Quality
http://informahealthcare.com/doi/abs/10.3109/08958378.2012.724728

Levels of selected carcinogens and toxicants in vapor from electronic cigarettes
http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.abstract

Does e-cigarette consumption cause passive vaping?
http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0668.2012.00792.x/abstract

Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM)
http://www.ncbi.nlm.nih.gov/pubmed/22913171

Secondhand Exposure to Vapors From Electronic Cigarettes
http://ntr.oxfordjournals.org/content/early/2013/12/10/ntr.ntt203.short

What Am I Inhaling?
As mentioned above, there are common ingredients for most e-liquids. What adverse effects can be found from these substances?

Propylene Glycol:
Propylene Glycol or (PG) is one of the primary ingredients in e-cigarettes. According to research studies dating back to the 1940’s, this ingredient has been used in inhalants for quite some time in devices such as asthma inhalers, air disinfectants in hospitals and restaurants, and entertainment centers as well such as theaters, bars, and restaurants. This substance is also a main ingredient of fog machines.

Is PG Safe? Should I be concerned?
“Propylene glycol is used in air sanitization and hard surface disinfection and dipropylene glycol is used in air sanitization.”
“Propylene glycol and dipropylene glycol were first registered in 1950 and 1959, respectively, by the FDA for use in hospitals as air disinfectants.”
“Indoor Non-Food: Propylene glycol is used on the following use sites: air treatment (eating establishments, hospital, commercial, institutional, household, bathroom, transportation facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; laundry equipment; hard non-porous surface treatments (bathroom facilities); automobiles; air conditioning filters; pet treatment, including cats, dogs, and caged birds; environmental inanimate hard surfaces; garbage containers/storage.”
“Target Pests: Odor-causing bacteria, Fleas, Mites, Red lice, Animal pathogenic bacteria (G- and G+ vegetative), Shigella bacteria, Pasteurella bacteria, Listeria bacteria, Herpes Simplex I and II, Animal viruses, Influenza Virus A2, Aspergillus Niger Fungus, Mold/Mildew, Pseudomonas SPP., Shigella Flexneri, Shigella Sonnei.”
General Toxicity Observations
“Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol. This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed.”

Carcinogenicity Classification
“A review of the available data has shown propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies conducted up to the testing limit doses established by the Agency; therefore, no further carcinogenic analysis is required.”

And there is much more information in the full document linked below:http://www.epa.gov/oppsrrd1/reregistration/REDs/propylene_glycol_red.pdf

Vegetable Glycerin:
Vegetable Glycerin or (VG) is also a main component used in e-liquids. VG is the substance in an e-liquid that makes the liquid thicker. It is a carbohydrate that is usually derived from plant oils. This substance is used as a sweetener in many foods as well. Most e-liquid providers now use USP Grade VG rather than Food Grade.

VG is also used in place of alcohol for many extracts. See: http://www.wisegeek.com/what-is-vegetable-glycerin.htm
Products with Vegetable Glycerin can be found in various common items around your house. A few examples include:
• Sugar substitute
• In Beauty products including makeup, mousse, shampoo, bubble bath, after shave, and deodorant
• Pet food
• Soap
• Skin and hand cream
• Baked goods – increase moisture
• As a thick gel for creams, gel capsule pills, rubs and jellies
• Eye & ear drops, toothpastes, pastes, and many dental care products

Glycerine is classified by the U.S. Food and Drug Administration (FDA) as “generally recognized as safe” (GRAS) and complies with specifications for the Food Chemicals Codex (FCC), United States Pharmacopeia (USP), and European Pharmacopoeia (Ph. Eur. or EP) E244. It is manufactured according to current Good Manufacturing Practices (cGMP) and is shipped according to applicable Good Trade and Distribution Practices (GTDP). See: http://msdssearch.dow.com/PublishedLiteratureDOWCOM/dh_091a/0901b8038091a41a.pdf?filepath=productsafety/pdfs/noreg/233-00490.pdf&fromPage=GetDoc

For more information on scientific and medical information on e-liquid and electronic cigarettes, please visit this webpage: http://www.vapersclub.com/science.php

What is the difference between USP Grade and Pharmaceutical Grade?
USP Grade materials allows for fillers and binders added during the manufacturing process, and the additives don’t have to be on the label per the FDA. Common fillers are things like corn sugars, and propleyene Glycol.

Pharmaceutical grade means the product was made using GMP, or Good Manufacturing Practices, and has to be 98-99.7% pure. For more information, please see: http://www.usp.org/food-ingredients

How Can Avomeen Help?
Avomeen’s laboratory performs a verity of e-liquid testing and development. Our chemical analysis can help you determine if your product is safe for consumption. Our labs include:
• Determine e-liquid recipes through chemical reverse engineering (if you wish to have a competitive edge on other distributors)
• Deformulation of e-liquid flavor profiles & identification of flavoring agents or additives used within a product’s formulation. We can help achieve the proper flavor with less additives.
• Carcinogenic analysis including toxic ingredient analysis for Diacetyl, Propinyl Acetyl, and Acetoin
• Analyze e-liquids for unknown ingredients and determine the purity and grade of its raw ingredients
• Test your e-liquid for nicotine levels to formulate accuracy (USP Assay)
• Metals VOC Analysis
• VG/PG ratio
• Safety Data Sheet
• Toxicology Testing – Verify the safety of your product
• Determine products shelf life under various storage conditions and give recommendations for storage and expiration for your customers
• Develop new custom formulation of e-liquid recipes

These services are primarily utilized by and conducted for manufacturers and distributors of e-liquid products. If you manufacture or distribute e-liquid products and you would like analysis done for safety, legal, buy confidence or any other purposes, give us a call for a free consolation with one of our PhD chemists. We have a full service chemical testing laboratory and can provide the e-liquid testing you desire!

202, 2016

Ink Manufacturing & Contaminant Risk

February 2nd, 2016|Blog|

Ink Manufacturing & Testing
Paint and ink manufacturing has been through dramatic changes due to a call for environmental and consumer protection awareness. Research surrounding harmful contaminants and their use has influenced government regulation, embodied by the Food & Drug Administration (FDA) and the Centers for Disease Control (CDC) in the United States, in most industries with the purpose of creating an informed public. The most common example in the paint and ink industry would be the ban of lead pigment-based paints in 1978. A toxic heavy metal, lead was found to negatively affect most systems in the body, especially the nervous system, over prolonged exposure causing cancer and other complications. The further discovery of materials that can contaminate or alter consumer paints and inks has led to the need for quality control as well as research and development devoted to more conscious products.

The possible contaminants found in the process of ink production is made up of ingredients, byproducts, and other materials the final product may come in contact with during manufacturing:
• Metals, such as chromium, cadmium, lead, and zinc
• VOCs (Volatile Organic Compounds)
• Chloroform
• Ethyl Benzene
• Various Solvents
• Residual Paint or Ink
• Bacteria, etc.

Most are not easily detectable due to their chemical properties, and require specialized processes to determine presence and levels. Bacteria were the subject of recent discussion surrounding tattoo ink in 2014 when tattoo recipients noticed symptoms such as fevers, rashes, and excessive pain. A California company was forced to recall when tests found evidence of bacteria in unopened bottles of ink. The FDA further warned that this had not been, and would not be, the only case of contaminated ink affecting consumers, and manufacturers.

Contaminated paints and inks present both potential health concerns and business-related obstacles. The list above contains multiple carcinogens and allergens harmful to the human body and the immediate environment. Each can be assumed to have properties that affect normal bodily processes in humans, at the very least causing headaches and skin irritation. Also, the potential for negative environmental consequences, especially in the form of waste, is noteworthy as it still directly affects the general population.

There are risks for manufacture companies in the industry as well. Clean up costs after the fact, including public relations, are the first to come to mind. But it is the quality of the product that is undermined by potential impurities. In an industry that already worries about the effect of the product on the consumer, maintaining a consistent product is important to longevity, both in profit and usefulness of a product. Consequently, taking the time to find impurities in a paint or ink product before market is an essential step in preventing recalls or other similar outcomes.
Contamination testing provides the answer in identifying a contaminant, if any, and in helping to find possible solutions for future batches. By adding a step for quality control testing into the overall production process, likely useless batches can be reversed more quickly allowing a manufacturer to minimize potentially harmful or low quality products to enter the market. At Avomeen our staff is skilled in various research methods, such as chemical testing, that help locate impurities to their smallest presence. Our results will give you the opportunity to make informed decisions in the future of your paint and ink production.

2101, 2015

Avomeen’s Pharmaceutical Development

January 21st, 2015|Blog|

Our 25,000 square foot laboratory includes 4 (ISO-7 Compliant) Clean Rooms and Dedicated Formulation Suites to serve our clients’ product development needs.

We provide CTM service for Phase I-IIa and partner with you from initial development to final registration. Our expert pharmaceutical scientists have over 30 years of experience providing solid and semi-solid dosage forms and are experts in bio-availability, protein analysis, API characterization, and much more.

Our production processes include:
Blending/Homogenization
Granulation, Compacting, Mixing, and Filling
Milling & Micronizing
Fluid bed coating and drying (Extrusion & High Shear)
Liquid & Cream Manufacturing
Powder Blending & Tableting
Container/Closure Selection
Pellet (Bead) & Powder Encapsulation

We also provide Method Development & Validation to meet the full range of your needs throughout the development cycle.

Contact our Ph.D. scientists for a consultation to see how we can meet your needs.

800.930.5450 | scientist@avomeen.comwww.avomeen.com/pharma

 

3007, 2014

The Uses of ASTM Standards for Chemical Analysis

July 30th, 2014|Blog|

Avomeen offers a wide variety of ASTM testing methods for chemical analysis and the characterization of compounds, materials, consumer goods, pharmaceuticals, and many other products. These testing methods provide an international standard by which various industries maintain regulatory commonality for quality control, contamination identification, formulation, trace analysis, investigative analysis, and more. These test are performed for a variety of industries including pharmaceuticals, automotive, cosmetics, food & beverage, medical devices and more.
Previously known as the American Society for Testing and Materials, ASTM International develops a range of consensus standards that are adopted and used globally across industries. The standards created by ASTM are designed to enhance safety and improve quality of consumer and industrial products. When a new industry seeks to develop standardization, companies in that industry often come together under ASTM in order to achieve the desired result. Over 12,000 ASTM standards are currently in use around the world, written by over 143 technical standards-writing committees.
The standards developed by ASTM International fall into six categories:
Standard Specification – to define the requirements the subject of the stand must satisfy
Standard Test Method – to define the way in which a test is performed and the necessary precision of the result
Standard Practice – to define a sequence of operations that does not produce a result
Standard Guide – to provide an organized collection of information or a list of options that does not mandate a specific course of action
Standard Classification – to provide an arrangement or division of products, systems, services, or materials into groups based on similar characteristics such as composition, properties, origin, or use
Terminology Standard – to provide agreed upon definitions of terms used in other standards
As a member of ASTM International, Avomeen performs these tests for a variety of industries and has the capacity to quote any ASTM test necessary for products including:
  •         Cleaning Products
  •        Cosmetics
  •         Adhesives & Sealants
  •          Medical Devices
  •          Food & Beverage
  •          Pharmaceutical & Supplements
  •          Paints & Coatings
  •          Plastics & Polymers
  •          Consumer Goods
  •          Petroleum
  •          Chemicals

For more information regarding Avomeen’s ASTM testing capabilities and to discuss your project needs with one of our expert chemists, call 800-930-5450 or email scientist@avomeen.com
207, 2014

Full-Time Equivalent Chemists Benefit Companies from Research to Manufacturing

July 2nd, 2014|Blog|

When you have a project needing focused attention contracting a Full-Time Equivalent (FTE) chemist can help you get results with a dedicated team working on your timeline. Clients contract one or more of Avomeen chemists to work full-time on their project and are charged a set fee for the hours worked. Upon project completion, the client then receives the rights to all formulation specifics. FTE are often employed for projects such as pharmaceutical research, method development and validation, or formulation feasibility analysis and development. 
 
Using FTE chemists ensures reliable service and efficiency as well as the flexibility to make project changes without re-defining scope of work or revising contracts. This is especially useful when employed for complex projects such as chemical analysis performed in preparation of an Investigational New Drug Application. Likewise, product development clients may also make use of FTE services in order to create multiple iterations of trial formulas without worrying about contracting a specific scope of work and being charged for additional product changes.
Why Contract Avomeen’s FTE Service?
  1. Experienced chemists with over 30 years of experience performing complex chemical analysis
  2. Access to state-of-the-art labs, instrumentation, and the latest methodology
  3. Fully customized services
  4. Project flexibility
  5. Direct communication with our expert chemists throughout the project
How the FTE Project Process Unfolds:
  1. Call us at 800-930-5450 or email scientist@avomeen.com to discuss your project specifics
  2. We will assign a Ph.D. chemist to oversee your project and develop a team to accomplish your goals
  3. Research begins and you are kept up-to-date on your project’s progression via communication directly with your team of chemists
  4. Upon project completion you receive a detailed final report and full rights to your product formulation or analytical results


2606, 2014

Medical Device Removed from Market Due to Life Threatening Manufacturing Error

June 26th, 2014|Blog|


This May Ventlab LLC. in Grand Rapids, Michigan, initiated a voluntary recall of resuscitator bags after discovering that the duckbill valve was sticking thereby preventing air to pass through the patient valve. The bags affected could be life threatening if used, as the lack of airflow could result in patient hypoxia and hypoventilation.

The product defect is thought to be due to incomplete curing during the manufacturing process. This error only effects certain lots and the full list of suspected failed lots can be found at:


Manufacturing errors such as incomplete curing are not an unusual failure, however they have dire consequences. There have been 31 reports of delayed medical care due to professionals having to use two or three of the resuscitation devices to assist a patient. There has also be one reported injury due to the defective bags.

Especially when it comes to medical devices, product defects and failures are of the utmost concern. Companies must take immediate action to not only remove the defective product from the market, but also to solve the production error by finding the source of the product defect. When this occurs the manufacturer is often unable to identify the cause of the failure and must consult expert help to pin point the defect source.

Avomeen Analytical Services provides exceptional product failure analysis. Utilizing state-of-the-art instrumentation and methodology our scientists examine products at the elemental level to isolate contaminants, compare good vs. batches of product, and determine the source of a manufacturing failure. These services help companies such as Ventlab identify and address their problem, allowing them to quickly resume production and sale of their medical devices.

More information regarding Avomeen’s Product Defect/Failure Analysis can be found on our website at:

For immediate assistance with product analysis call us at 800-930-5450or email Scientist@avomeen.com

We look forward to working with you to solve your complex production problems!
1306, 2014

Avomeen Invites Attendees at BIO 2014 International Convention to Connect at Booth #1259

June 13th, 2014|Blog|

June 23-26, 2014 Avomeen will be exhibiting their wide range of pharmaceutical services at this year’s 2014 BIO Convention. They invite all attendees to visit their booth #1259 to learn more about how their specialized chemists can solve even the toughest problems throughout the pharmaceutical development process. As a top contract research organization (CRO) we offer services from pre-formulation through to stability analysis.

Our chemists have over 30 years of experience providing expert analysis for early stage drug development through to extractables/leachables testing and so much more. We are excited to share our skills with the thousands of organizations attending the event this year and hope to develop lasting relationships to benefit attendees’ current and future project needs.

Many biotech companies, pharmaceutical researchers, and academic institutions come to BIO with specific questions and current project needs already in mind. Avomeen’s representatives will be meeting individuals at booth #1259 to set up consultations and provide answers to even the toughest of these problems.
Whether your company is attending the conference with current analytical testing needs, or simply looking to network for future collaboration, we hope to meet you at this year’s convention.

Our pharmaceutical services include:
  • ·         Method Development & Validation
  • ·         Preformulation & Formulation
  • ·         Extractables & Leachables
  • ·         Stability & Release Testing
  • ·         Degradation Analysis
  • ·         Clinical Trial Manufacturing
  • ·         Defect & Failure Analysis
  • ·         Counterfeit Analysis
  • ·         Litigation Support Services

Call our Ph.D. scientist today to receive an initial consultation and visit us at BIO to discover how we can take you product to the next step.

Phone: 800-930-5450

206, 2014

Michigan’s Great Lakes Threatened by Pollution Caused from Cosmetic Microbeads – New Study Reveals

June 2nd, 2014|Blog|

06/02/14 – NPR recently reported Dr. Sherri Mason’s research on the newest pollutant in the Great Lakes, cosmetic microbeads.  These beads which are used in a variety of exfoliating body scrubs, facial cleaners, and other cosmetic products are actually tiny pieces of plastic.  Lead by Professor Mason the State University of New York at Fredonia students collected samples of debris in the lakes by dragging a net that caught all objects greater than a third of a millimeter.

This sampling revealed there to be approximately 17,000 of these plastic pieces per square kilometer in Lake Michigan.  Lake Erie and Ontario have higher levels of plastic particles while Lake Huron and Superior have lower.
The concern of these bits of plastic entering the lakes revolves around their impact to the total ecosystem.  Primarily, these beads are thought to potentially increase the level of harmful toxins entering the food chain.  These microbeads can absorb toxins and the researchers are concerned that those toxic chemicals could then be passed to wildlife and eventually humans as the beads are so small in size they appear as food to many organisms living in the water. 
These findings are effecting New York legislature as a ban on microbeads is quickly rising through legislative branches. If this legislation is indeed made law, New York manufacturers will only have until December of 2015 to completely phase out products with microbeads. This legislative change will not only effect New York but equivalent laws are making their way through Illinois while the other lake states are thought to quickly join suite.
Product manufacturers are urged to proactively begin creating alternative products with natural exfoliants such as apricot seeds, sand, or cocoa beans.  Avomeen’s product development laboratory has already helped manufacturers reformulate facial scrubs modifying their formulations to include alternative bio-degradable materials instead of utilizing microbeads.  Avomeen’s  CEO Shri Thanedar Ph.D. hopes more companies will realize that their products’ formulations can be reformulated or re-engineered to remove harmful ingredients while creating an end product that meets the same or even improved upon specifications as the original product.
Reach out to Avomeen’s skilled chemists today for a complimentary initial consultation and see how they  can help you keep the Great Lakes clean, protect your brands image, and keep your products ahead of upcoming legislative changes.
Avomeen Analytical Services
Product Testing & Formulation Development Laboratory
4840 Venture Drive
Ann Arbor, MI 48108
Phone: 800-930-5450

505, 2014

Extractables and Leachables USA 2014 Conference Sponsor

May 5th, 2014|Blog|

Extractables and Leachables (E&L) are a growing concern in the world of pharmaceutical packaging. With new FDA protocols and industry best practices ever changing it is important for pharmaceutical researchers and manufacturers to know what to expect of their E&L testing and how to ensure proper documentation for NDA/ANDA submission. The two day conference will host to over 18 extraordinary speakers as laboratories, research institutions, pharmaceutical companies, and others gather to learn the latest in this quickly changing field.

Avomeen’s scientists will be present to offer their expertise in E&L method development, method validation, and testing. We will also be hosting the May 8th luncheon to provide attendees an additional opportunity to share ideas in the field of extractables and leachables.

To find out more regarding our E&L services visit www.avomeen.com/e&l and go to www.avomeen.com/casestudy/eandl for a case study outlining how our extensive E&L capabilities can solve even the toughest of problems.

To those attending this year’s Extractables and Leachables USA conference we look forward to meeting you and determining how Avomeen’s skilled scientists can solve your complex E&L problems.

1804, 2014

American Coatings SHOW 2014 – A Thank You

April 18th, 2014|Blog|

The 2014 American Coatings SHOW in Atlanta, GA was a spectacular show. Avomeen participated in the SHOWs emphasis on development and discovery in the paints and coatings industry by offering our unique services to the industry’s top professionals. During the show we enjoyed networking with others in the field of coatings formulation and conducted onsite consultations for vexing coatings problems. Our scientists had the chance to discuss projects requiring a vast number of our unique services including:

  • VOC Testing
  • Contaminant Identification
  • Failure/Defect Analysis
  • Formulation Development
  • Deformulation/Reverse Engineering
  • Product Reformulation
  • Certification & Verification
  • Competitor Product Analysis
To those we had the privilege of speaking with, we look forward to continuing to discuss how we can meet your development and testing needs. To those who missed us or were unable to attend this year’s show we invite you to join us next year, but urge you to not wait until then to discover how our customized testing and formulations services can meet your needs. Visit us today at www.avomeen.com/coatings or call 800.930.5450 to speak directly with one of our Ph.D. chemists.
Thank you to everyone who joined us at this year’s American Coatings SHOW to discover the best ways to innovate and provide premium products to the marketplace.