Tobacco – Smoke – e-Vapor (TSV)

Tobacco – Smoke – e-Vapor (TSV)

Montrose Environmental Group has been analyzing tobacco products since 2000 and is a leading independent tobacco, smoke, and e-Vapor testing laboratory offering regulatory and research services. Montrose Environmental Group operates two TSV laboratories: one in Richmond, VA (formerly Arista Laboratories), and one in Durham, NC, boasting over 60,000 ft2 combined laboratory space. Our internationally accredited laboratories are equipped with modern linear and rotary smoking machines and an array of analytical systems designed for the collection, analysis, and reporting of traditional tobacco products as well as electronic cigarettes. Client projects are managed in a secure work and data environment following strict quality and security guidelines. Montrose Environmental Group is committed to providing customers with robust testing yielding accurate and timely results with unmatched customer service.

Our TSV analysis methods are internationally accredited by A2LA to the ISO 17025 standard. Montrose Environmental Group operates under a comprehensive quality assurance (QA) system designed to ensure the validity, reproducibility, and accuracy of all our measurements. The Richmond, VA, laboratory is also certified to offer testing under Good Laboratory Practices (GLP) guidelines. Our quality assurance program includes the company’s Quality Assurance Plan (QAP), Handbook of Standard Operating Procedures (SOPs), and the standard methodologies published by international, federal, and industry organizations.

You will benefit from both the quality of our testing and our client-focused service. Our goal is to deliver the most accurate results available and to do so in a timely manner. We will provide you with unparalleled service at a competitive price. For over 20 years, Montrose Environmental Group has excelled as a project-oriented lab. We will provide your tobacco or electronic cigarette testing quickly, effectively, and conscientiously.

Montrose Environmental Group offers a range of test methods for the collection and analysis of harmful and potentially harmful constituents (HPHCs) in tobacco, mainstream smoke (MSS), and side stream smoke (SSS). Methods include the analysis of tar, nicotine, carbon monoxide (TNCO) and the list of “Hoffmann analytes”, as well as the full list of 93 FDA HPHCs.

Our experts operate three smoke labs between the Richmond and Durham laboratories, allowing for redundancy and flexibility in our testing processes.  Environmental conditions in our smoke labs are maintained to exacting specifications for humidity and temperature control using custom environmental control systems. Equipment within the lab is supported by emergency backup generators and uninterruptable power sources (UPS). Montrose Environmental Group houses quality controlled facilities for conditioned storage and sample preparation. Dedicated freezers and refrigerators are available for segregated storage of samples and analytical standards. All laboratory data collected from smoking machine runs and analytical system outputs are stored on a secure, access-limited network with firewall and intrusion protection systems.

The science of analyzing tobacco products poses many unique challenges; these are highly complex matrices from which to generate samples suitable for instrumental analysis. The process of creating these samples requires the development and implementation of cutting-edge techniques to manipulate both cigarettes and smokeless tobacco products.

Our project scientists’ thorough knowledge of FDA harmful and potentially harmful constituents (HPHC) in tobacco and smoke has allowed for quick and robust method transfer to cigar and pipe tobacco to meet the requirements of the FDA’s Deeming Regulations for cigar and pipe products published on May 10, 2016.

Researchers from Montrose Environmental Group utilize nationally and internationally accepted test methods – enhanced and adapted for our laboratories – to deliver consistent, high-quality data. Each HPHC project we conduct is generated under our rigorous ISO 17025 quality system, meaning the procedures used to generate your data are reliable and will stand-up to scrutiny from inside and outside your organization. In addition to HPHC testing, we also have methods in place for routine product testing including methods for product moisture, menthol, cigarette physical properties, and certification of lowered ignition propensity (LIP) testing.

Montrose Environmental Group Cigarette Smoke & Filler services fulfill the requirements of:
• Health Canada
• ANVISA (Brazil)
• FDA (USA) 2012 Abbreviated HPHC Testing
• FDA (USA) Substantial Equivalence (SE) Testing
• Ignition Propensity (LIP) – ASTM Method E2187-09, ISO Standard 12863

Montrose Environmental Group offers a range of test methods for the collection and analysis of harmful and potentially harmful constituents (HPHCs) in smokeless tobacco products including snus and snuff. This includes methods that cover a range of compounds including nicotine and the list of FDA HPHCs.

Our tobacco testing laboratories located in Richmond and Durham offer clients redundancy and flexibility in our testing processes. Equipment within the labs is supported by a backup electric generator and uninterruptable power system (UPS). In addition to traditional HPHC testing of smokeless tobacco, Montrose Environmental Group can assist clients with long-term stability projects with on-site storage capabilities, flavor marker testing, as well as the analysis of client generated in-vitro samples.

The science of analyzing tobacco products poses many unique challenges; these are highly complex matrices from which to generate samples suitable for instrumental analysis. Our project scientists utilize internationally recognized accepted test methods, enhanced and adapted for our laboratory, to deliver consistently high-quality data. Each smokeless tobacco project we conduct is generated under our rigorous ISO 17025 quality system, meaning the procedures used to generate your data are reliable and will withstand scrutiny from inside and outside your organization. All laboratory data collected from analytical system outputs are stored on a secure, access-limited network with firewall and intrusion protection systems.

Montrose Environmental Group Smokeless Tobacco Product services fulfill the requirements of:

  • Health Canada
  • ANVISA (Brazil)
  • FDA (USA) 2012 Abbreviated HPHC Testing
  • FDA (USA) Substantial Equivalence (SE) Testing
  • Analyses consistent with the Gothia Tek® standard developed by Swedish Match

Prior to Deeming Regulations for e-Vapor products published on May 10, 2016, we had analyzed thousands of e-Vapor devices and liquids for hundreds of manufacturers, vendors, and consumers. Our thorough knowledge of FDA harmful and potentially harmful constituents (HPHC) in tobacco and smoke has allowed for quick and robust method transfer to e-Vapor products.

Montrose Environmental Group operates three smoke labs capable of e-Vapor sample collection between its Richmond and Durham laboratories, allowing for redundancy and flexibility in our testing processes. Montrose Environmental Group offers analysis and testing of e-Vapor and e-Liquids for the presence of nicotine, propylene glycol, glycerin, carbonyls (i.e. diacetyl, formaldehyde, etc.), particle sizing, and the FDA’s abbreviated list of HPHCs, including tobacco specific nitrosamines (TSNA). Montrose Environmental Group has analytical methods in place to meet requirements of the 2016 FDA Deeming Regulations and European Union Tobacco Product Directive (EU-TPD).

Our scientists utilize internationally recognized test methods, enhanced and adapted for our laboratories, to deliver accurate, reliable, consistently high-quality data. All e-vapor and e-liquid methods have been validated for quality assurance, including evaluation for linearity, recovery from the matrix, and verification of detection limits. All analytical equipment is qualified and calibrated with full documentation. Our laboratories offer testing that is internationally accredited by A2LA to the ISO 17025 standard.

Montrose Environmental Group Smokeless Tobacco Product services fulfill the requirements of:
• FDA (USA) HPHC Testing
• FDA (USA) Substantial Equivalence (SE) Testing
• FDA (USA) Premarket Tobacco Application (PMTA) Testing
• EU-TPD Testing

Montrose Environmental Group is the leader in Fire Safe Cigarette (FSC) testing for lower ignition propensity (LIP / IP). With a dedicated 2,000 ft2 LIP laboratory space, we can run up to 50 individual SKUs per week. All testing is accredited by A2LA and meets or exceeds the requirements of ASTM Method E2187-09, “Standard Test Method for Measuring the Ignition Strength of Cigarettes” and ISO Standard 12863 “Standard Test Method for Assessing the Ignition Propensity of Cigarettes.”

LIP testing is conducted on 10 layers of filter paper with 40 replicates (cigarettes) per SKU. An evaluation of “PASS” indicates the samples meet a performance standard where no more than 25 percent of the cigarettes tested exhibit full length burns. A certificate of analysis is provided for all samples rated as a “PASS” that is suitable for direct submission to national and state authorities.

Montrose Environmental Group provides in vitro toxicology services for tobacco, smoke and e-Vapor. Through the utilization of specialized tools, we are able to study early and late genotoxic and cytotoxic effects of individual compounds and various materials (i.e., plant, animal and human tissues, agrochemicals, drugs, personal care products, and natural products). All testing performed in our toxicology department is conducted following GLP guidelines. These capabilities allow us to test products at various physical phases (gas, solid, liquid). We provide testing services to a wide spectrum of customers including commercial, governmental, and regulatory agencies.

Services include, but are not limited to:

  • mutagenicity (Ames);
  • cytotoxicity (neutral red uptake);
  • clastogenicity/aneugenicity (micronucleus) in particulate, vapor, and whole smoke phases. 
  • bacteria, yeast and mold enumeration;
  • irritation tests;
  • sister chromatid exchange (SCE);
  • assays using animal or human primary or immortalized cell lines;
  • 3-D human and animal tissue models; and
  • stability testing. 

Mutagenicity findings are evaluated and interpreted using a proprietary VISITOX interface to the SALM statistical software program developed at the University of North Carolina. This interface is available to independent researchers for the evaluation of their own data through the laboratory’s secure client login interface.

Montrose Environmental Group In Vitro Toxicology services fulfill the requirements of:
• Health Canada
• ANVISA (Brazil)
• FDA (USA) HPHC Testing
• FDA (USA) Substantial Equivalence (SE) Testing

For over 15 years, Montrose Environmental Group has assisted clients with short and long-term stability projects for Tobacco and e-Vapor Products. Our extensive program offers on-site and off-site storage facilities which are fully validated, continuously monitored storage environments for ICH and WHO test conditions for both temperature and humidity control.

Montrose Environmental Group offers stability testing encompassing various sample storage conditions for the evaluation of e-liquid and e-cigarette product lifetimes. We can also support study design and management of forced degradation studies to assess the “stability-indicating” power of the analytical methods under development for stability testing.

We remain a project-oriented laboratory, which makes us an invaluable resource for product stability testing. All stability projects are managed by a primary Montrose Environmental Group project manager with an assigned back-up to ensure schedules are never compromised and clients have a singular point of contact. From stability time points that range from weeks to years, Montrose Environmental Group has assisted manufacturers, regulatory agencies, and academia with Tobacco and e-Vapor stability projects.

Storage Conditions Offered:
• 25 °C ± 2 °C/60% RH ± 5% RH (Standard)
• 40 °C ± 2 °C/75% RH ± 5% RH (Accelerated)
• -20 °C ± 5 °C (Control)
• 30 °C ± 2 °C/65% RH ± 5% RH
• 40 °C ± 2 °C/25% RH ± 5% RH
• 30 °C ± 2 °C/75% RH ± 5% RH
• 25 °C ± 2 °C/40% RH ± 5% RH

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