Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs)

Over the years we have compiled a library of frequently asked questions, for many of our businesses.  This library is constantly being updated.

Summary

Per- and Polyfluorinated Alkyl Substances (PFAS)

Perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA) and related per- and polyfluorinated alkyl substances (PFAS) continue to receive a substantial amount of attention from environmental practitioners and regulatory bodies, not only because they are recognized as ubiquitous environmental contaminants, but also because these compounds persist, bioaccumulate and cause toxicity in some animal studies. PFAS are of particular interest because of their emergence as compounds of environmental concern at an increasing number of sites across North America.

INTRODUCTION

Over the last several years, requirements for PFAS analyses, and the ability to use the resultant data for risk assessment and management, as well as remedial decisions have increased at an extraordinary rate. Because of the recognized challenges associated with proper sampling and analysis of these compounds, questions about sampling, analysis and correct interpretation of analytical results provided by laboratories have also increased. It is important that the laboratory industry respond not only with reliable, defensible and comparable analytical results, but also consistent responses to these questions to ensure a sound and uniform decision making framework for the data user

PFAS NAMING CONVENTIONS

WHAT IS PFAS?

PFAS is an acronym for the entire class of per- and polyfluorinated alkyl substances. The class of compounds eencompasses a whole family of man-made chemicals used in industry and consumer products worldwide since the 1950s. PFAS represents over 3,000 substances that contain a carbon and fluorine atom backbone. Many are extremely persistent and mobile in the environment.

The most commonly studied PFAS are perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). Then next most studied are perfluorohexane sulfonic acid (PFHxS) and perfluorononanoic acid (PFNA). PFAS, as an abbreviation, is a plural noun. It should be noted that the acronym PFCs (perfluorinated compounds) is no longer used as it is poorly defined and does not capture the polyfluorinated compounds which are being increasingly recognised as environmental contaminants.

SAMPLE CONTAMINATION

The drive to decrease PFAS criteria to low ng/L has resulted in the need for increased sensitivity in the analyses.

WHAT ARE COMMON SOURCES OF SAMPLE CONTAMINATION?

Sampling Equipment

A known source of background contamination is the presence of fluoropolymers, such as polytetrafluoroethylene (PTFE) compounds in sampling equipment such as pump tubing.

Sample Containers

Glass containers are not suitable for the collection and storage of samples due to the potential for adsorption of PFAS on the walls of these containers.

Samples should be collected in high density polyethylene (HDPE) bottles, provided by the laboratory and fitted with an unlined (Teflon-free) polypropylene screw cap.

Because of the ubiquitous nature of PFAS compounds in many modern materials, all batches of sample containers provided by Bureau Veritas, used for collecting samples for PFAS determinations, are “proofed” to demonstrate that they are PFAS-free prior to sampling.

Field / Wash Water

Water used in the field to generate quality control (QC) samples should be PFAS-free. Bureau Veritas will provide for a fee, PFAS-free water that has been “proofed” by the laboratory.

Other Sources of Contamination

There are reports that some personal care products such as cosmetics, moisturizers and sunblock contain PFAS and should not be worn by the sampler to limit any potential contamination.

SAMPLE PRESERVATION

WHAT IS THE PURPOSE OF TRIZMA PRESERVATIVE?

USEPA methods for regulated drinking water typically use sample preservatives to prevent microbial degradation (e.g. CuSO4, DZU and NaHSO4) and to dechlorinate (e.g. ascorbic acid, Trizma buffer and Na2SO3) at the time of sampling.

Bureau Veritas selected Trizma buffer as the preferred preservative as it yields recoveries of PFAS between 92 – 108% with excellent precision. It has the added benefit of buffering the sample at pH 7.

SAMPLE HANDLING

WHAT IS THE PROCEDURE FOR HANDLING TURBID SAMPLES OR SAMPLES CONTAINING SEDIMENT?

Turbid samples should either be centrifuged or allowed to settle prior to sampling the supernatant. In situations where low levels of PFAS are anticipated, the whole bottle is extracted. It should be recognized that this potentially introduces a high bias because PFAS that is adsorbed to the particulate material may contribute to the total PFAS concentration

SHOULD A SAMPLE CONTAINING A LOT OF SEDIMENT BE FILTERED?

No. The accepted industry best practice is that samples collected for PFAS determinations should not be filtered as it has been demonstrated that significant PFAS loss can occur due to adsorption on to the surface of the filter, as shown in Table 1.

Table 1: PFAS – Filtered vs. centrifuged

PFAS Filtered (ng/L) Centrifuged (ng/L)
PFOS 29.3 96.6

QUANTIFYING PFAS

WHAT ARE THE IMPORTANT CONSIDERATIONS WHEN CALCULATING PFAS?

Isotope Dilution Mass Spectrometry (IDMS)

IDMS provides greater accuracy than other calibration methods because it compensates for any matrix effects that may suppress recovery of the parameters being measured.

Simply put, the recovery of the labeled compound, which is not naturally present in the sample, is an exact representation of the recovery of the native compound which is present in the sample. IDMS involves using the isotopically labelled analogue for each target compound determined.

Direct Injection vs. Solid Phase Extraction (SPE)

Water samples containing low levels of PFAS undergo a solid phase extraction (SPE), to extract, clean up and concentrate the parameters of concern. The extract is then analysed by isotope dilution liquid chromatography coupled with tandem mass spectrometry (LC/MS/MS).

Water samples with higher PFAS concentrations may be analysed by direct injection isotope dilution (LC/MS/MS).

Soil, solids and tissues are homogenised, followed by a solid/liquid extraction. Interferences are removed from the liquid extract using SPE. The extract is then concentrated and analysed by isotope dilution LC/MS/MS.

WHY IS IT IMPORTANT TO DISTINGUISH BETWEEN LINEAR AND BRANCHED ISOMERS OF SPECIFIC PFAAS?

Most environmental contamination by PFAS is due to technical mixtures, not the just the linear isomer. Therefore, it is important to understand if PFAS such as PFOS was quantified using only the linear isomer or a technical mixture of the linear and branched isomers. If the calibration of the measurement system was performed using only the linear isomer, the final result for may be significantly biased (40 – 80%).

IN SUMMARY

This bulletin lists some of the most frequently asked questions received by Bureau Veritas regarding PFAS sampling and analysis. As technology advances and our knowledge surrounding the science of PFAS in the environment increases, new questions arise. For any enquiries concerning sampling and analysis for PFAS, please contact a Bureau Veritas expert.

ENVIRONMENTAL DNA (eDNA)

Environmental DNA (eDNA) is quickly gaining attention as a tool for ecological surveying. It is gaining popularity due to its accuracy, compared to intrusive traditional methods. Below is a selection of Frequently Asked Questions on this topic, complementing Bureau Veritas’ technical webinar. Questions related to this method are either focused on applicability or analytical considerations.

APPLICABILITY OF eDNA

1. HOW DOES eDNA WORK AND WHAT ARE THE ADVANTAGES OF eDNA TESTING?

eDNA testing is cost effective, more accurate than traditional methods, has less risk of pathogen transfer, and is less invasive to species (especially at-risk species) and ecosystems. The eDNA tests can be performed for multiple species using a single sample and it provides early detection of invasive species. This molecular biology method detects DNA of target species through quantitative polymerase chain reaction (qPCR) using the TaqMan® Assay.

2. CAN THE PRESENCE OF SPECIFIC FISH SPECIES BE CONFIRMED THROUGH THE EFISH eDNA ASSAY?

Our current eFish eDNA assay tests for the presence of a group of 12 fish species: Sockeye salmon, Pink salmon, Chum salmon, Arctic Grayling, Cutthroat trout, Rainbow trout/Steelhead, Chinook salmon, Coho salmon, Atlantic Salmon, Dolly Varden, Round Whitefish, and Slimy Sculpin. It does not identify a specific species. The test can be reported as “detected” of any one specie or as “not detected” result.

3. CAN DNA FROM A SPECIES OF FISH THAT NO LONGER LIVES IN A WATERCOURSE, REMAIN IN THE HABITAT FOR SOME TIME AND BIAS THE RESULTS?

Generally, eDNA persists in the environment for a short time. The duration is dependent on environmental conditions but is quantified, in standard conditions, between 4-58 days. So within this time frame, it is still possible to determine the presence of fish species that may no longer be present in the watercourse

4. WHAT IS THE APPLICABILITY OF THE METHOD TO TERRESTRIAL, OR SEMI-AQUATIC SPECIES? IS A FULLY AQUATIC LIFE STAGE MANDATORY FOR USING THE METHOD?

Suspension of eDNA in water allows for transport (active or through osmotic diffusion) through the system (transport distances are variable and depend on output rates, flow, etc.).  When suspended and transported in water, eDNA can be easily captured, extracted and tested for the focal taxa. eDNA methods can also be applied to terrestrial habitats, but advantages conferred by aquatic systems are lacking. Hence, design considerations are even more critical and false negatives are more likely. eDNA has just been applied successfully on Sharp-tailed snake (Contia tenuis). So it can be done but it’s not the ‘norm’.

5. HOW ARE HYBRIDIZATION ISSUES ADDRESSED, FOR EXAMPLE, BETWEEN RAINBOW AND CUTTHROAT TROUT, OR SUBSPECIES?

eDNA detects mitochondrial DNA. Thus, only the maternal lineage would be detected and subspecies cannot be identified.

6. DOES eDNA SETTLE IN LAKES? SHOULD SAMPLES BE COLLECTED FURTHER DOWN THE WATER COLUMN?

Research is ongoing regarding distribution and persistence of eDNA in environments.  However, at this time, there is evidence suggesting that most eDNA is found close to the area the animal can be found, likely because of degradation.  Thus, an understanding of the ecology of the organism is important for determining where to best collect samples.

ANALYTICAL CONSIDERATIONS FOR eDNA

7. WHAT VOLUME OF WATER IS REQUIRED PER SAMPLE?

The ideal volume required is 1L of water which is to be filtered through a cellulose nitrate filter (45µm pore size). This increases detection probabilities, however in some cases this volume may not be possible due to filter clogging. The minimum volume to be passed through the filter is 70ml.

8. WHAT TYPE OF CONTAINERS ARE REQUIRED? DOES BUREAU VERITAS PROVIDE THESE? WHAT IS THE HOLD TIME AND SHOULD SAMPLES BE SUBMITTED ON ICE AT <10C?

The intent is to eventually provide sampling kits, including required containers and filters but these are not supplied by Bureau Veritas at this time. It is not necessary to submit preserved filters on ice, and samples should be filtered prior to submission to maximize the potential DNA recovery and reduce the amount of degradation. Water samples should be collected in 1L Nalgene bottles. If the water sample is to be filtered in the field, insert the rolled-up filter in a 2mL tube, preserved with ethanol or silica and then transport to the lab.

9. HOW QUICKLY SHOULD SAMPLES BE SUBMITTED TO THE LABORATORY AFTER FILTRATION? HOW LONG DO PRESERVED SAMPLES LAST?

It depends on the contents of the water sample and what remains on the filter. Filtering the water sample and preserving the filter within 24 hours of sample collection is the recommended approach. Preserved filters should be sent to the laboratory to have eDNA recovered as soon as possible. There is no definite or standard time frame because the degradation rate will be related to properties of the microbial community of the sample. The ability to detect eDNA from target species does demonstrably decline over time from stored filter samples. Extracted eDNA is retained in a buffered solution and it is more stable than eDNA on the filter.

10. WHAT IS THE DETECTION LIMIT? I.E HOW MANY FISH NEED TO BE PRESENT IN A STREAM TO SHED ENOUGH DNA FOR A POSITIVE RESULT?

Detection of eDNA is not related as closely to abundance as it is to proximity.  It is possible to detect eDNA from one animal if enough cells were shed recently and very close to the sampling site.  That being said, if sampling did not occur close enough to these organisms, it is possible that no DNA would be present in the sample, and would not be detected.

11. HOW MANY SPECIES ARE AVAILABLE FOR THE eDNA ASSAY? IS THIS LIBRARY COLLABORATIVE ACROSS THE COUNTRY?

Each eDNA assay (other than eFish) has been designed for a specific species. Bureau Veritas Laboratories currently has 14 validated eDNA assays, and we are working to validate more species (as presented in the webinar). These validations are aligned with 13 additional assays developed at the University of Victoria, BC. There is no collaborative library across the country.

12. ARE THERE ANY CHALLENGES WITH COLLECTING, TRANSPORTING AND PRESERVING SAMPLES WHEN WORKING AT REMOTE SITES? OR ALTERNATIVELY, HOW DO SAMPLES NEED TO BE HANDLED AND HOW LONG CAN IT TAKE BETWEEN COLLECTION AND LAB PROCESSING?

There are considerations around these aspects that are easily accommodated by sound sample design. The standards to sample collection, preservation and submission for laboratory analysis are documented in the Protocol prepared for the British Columbia Ministry of Environment. 

13. DOES BUREAU VERITAS USE EXTERNALLY DEVELOPED ASSAYS FOR SPECIES NOT COVERED BY THE CURRENT METHOD?

Bureau Veritas’ focus is not on developing new assays. Typically, we use developed assays that are revalidated in-house and applied to commercial testing. However, if we are provided with a developed assay, revalidation of applicability for species and commercial testing can be done. This ensures that the assays have been designed properly and they do not detect closely related species or sympatric species.

ONTARIO DRINKING WATER

1. DOES BUREAU VERITAS PERFORM DRINKING WATER TESTING FOR ONTARIO?

Yes we do. For details on the options available, sampling instructions and links to the government guidelines and regulations, please click here. Our’s main lab facility in Mississauga, Ontario is accredited by SCC for all analyses performed on water samples.

2. DOES BUREAU VERITAS OFFER ANY ANALYSIS OF PRIVATE RESIDENCE POTABLE WATER?

Bureau Veritas’ Routine Comprehensive Package (RCAp) is specifically for testing drinking water from private residences. Contact ONwater@bvlabs.com for a full list of the tests included in this package. Clients are able to add and remove analyses to accommodate their specific concerns and needs.

3. CAN BUREAU VERITAS TELL ME IF MY WATER IS SAFE TO DRINK?

No. As an analytical laboratory, Bureau Veritas cannot state whether water is potable or safe for drinking. We provide quality analytical results for the parameters you request us to test for. We are however able to test for almost the full scope of the Safe Drinking Water Act. Reports include Ontario’s standards for clients to be able to compare where results stand in comparison to the provincial standards.

4. WHAT IS INCLUDED IN THE COST OF TESTING?

Bureau Veritas provides all the required sampling containers that are shipped to our clients free! The cost covers containers, analysis, final report and access to a customer service representative to answer any of your questions. It would be your responsibility to collect the sample and deliver it to our main lab located at 6740 Campobello Road in Mississauga.

5. WHAT IS THE PROCESS AND HOW DO I GET STARTED?

Email ONwater@bvlabs.com or call us at 905 817 5700 to speak to someone about your water concerns. We will then provide a quote based on your requirements. If you decide to proceed, Bureau Veritas will send sampling containers via courier service to any location within Ontario. The turnaround time is based on the analysis you request and is counted from the day your samples are delivered to the lab. Reports can be issued via email, fax or hard copy.

ULTRATRACE METALS ANALYSES

Many metals, when dissolved in waters can be toxic to plants, animals and people.   Some metal compounds can be acutely toxic at very low levels. Others can accumulate in plants or animals, building up to higher concentrations.  This `bioaccumulation` can results in toxic levels of some metals (mercury compounds are well known for this effect).

For these reasons, many governments have strict regulations regarding the amount of metals that can be discharged into the environment.   These `regulatory drivers` are the primary targets for our testing protocols.  In addition to Regulatory Guidelines and Limits, Agencies are requiring that industry not impair the aqueous environment in any way and as a result laboratories have been required to report metals to lower and lower levels.

Fortunately, instrumentation has improved greatly over the past few years to the point where ultratrace metals analysis is not limited by the instrument but rather the cleanliness of the sampling and sample handling techniques.  Our laboratories employ clean rooms to minimize laboratory sources of contamination and prove clean our containers and preservatives but what about the field environment?

One limitation of the instrumentation is that the ultratrace reporting limits cannot be achieved on samples with high dissolved solids (> 1%) and the method is not appropriate for such samples.

1. WHAT ARE IMPORTANT CONSIDERATIONS WHEN COLLECTING SAMPLES FOR LOW LEVEL METALS ANALYSES?

When collecting samples for ultratrace metals analyses, it is important to ensure that the samples that are ultimately analysed by the laboratory are representative of the environmental conditions from which the samples were collected.  Therefore, the samples must be collected in a manner and in containers that maintain the integrity of the sample and the metals being measured from the time the sample is collected to the time it is analyzed by the laboratory.

It is also important to minimize exposure of the sample to the ambient environment.  Extraneous contamination by metals in the sampling environment is a risk that increases significantly as the requirement for increased analytical sensitivity increases.  Metal contamination can occur almost anywhere from many different sources including: dust; automobile exhaust; cigarette smoke; some personal care products; etc.   It is important, therefore, to keep sample containers capped until the sample is collected.  Then cap the sample container as soon as possible after collection, keeping them sealed until they are opened by the laboratory.

2. WHAT ARE APPROPRIATE SAMPLE CONTAINERS FOR THE DETERMINATION OF LOW LEVEL METALS?

Sample containers for ultratrace metals analyses should be inert to the metals of interest.  Metals should not leach from the container, nor should any metals “stick” to the container walls.  Sample containers are “proofed” to ensure that they are not a source of metals themselves.

For ultra-trace testing of waters, containers and preservatives are proven free of metals to the part per trillion range.   Glass is not used for water samples because it contains significant levels of many metals.  Similarly, acid preservatives can contain significant levels of metals. High Density Polyethylene (HDPE) is a common choice for sampling waters for trace metals. It is light, impermeable to water and resistant to breaking.  Different brands can contain some metals, however.  Bureau Veritas has exhaustively researched to find the cleanest HDPE containers and preservatives available.

3. DO I NEED TO FILTER MY WATER SAMPLES IN THE FIELD?

In general, surface waters are analyzed for total metals and groundwaters for dissolved metals.  Drinking waters must be analyzed for total metals.  In some situations, e.g. environmental modelling, background studies, it may be beneficial to analyze for both total and dissolved metals.

When testing for dissolved metals at routine Regulatory levels, it is recommended to field filter the sample through a proven clean 0.45 μm filter1 prior to preservation with acid. If the sample is not filtered, then some particulate matter may be dissolved by the acid preservative.  This would result in high bias for dissolved metals.  Unfiltered, preserved samples are unsuitable for filtration at the laboratory.

For ultratrace analysis, our experience has shown that it is extremely difficult to field filter without introducing contamination.  For that reason, we recommend either the use of a specially designed Bureau Veritas field filtration kit, or filtration in the lab under clean room conditions.  Although it is possible that some analytes may dissolve or precipitate between sampling and lab filtration / preservation, these changes are small compared to the issues associated with field filtration.  Transport the sample to the lab asap to minimize any changes.

4. IS IT NECESSARY TO PRESERVE WATER SAMPLES FOR METALS ANALYSES?

When collecting samples for environmental analyses, it is important that the sample remains in the same “state” as it was when it was sampled.   Sample preservation for trace metals helps to ensure that the metals in the sample bottle stay at the same concentration as when they were sampled.   For most metals, adding nitric acid (HNO3) to lower the sample pH to < 2 will ensure that the metals of interest remain in solution.  For mercury analyses, hydrochloric acid (HCl) is typically used as a preservative.

5. WHAT IS THE MINIMUM SAMPLE SIZE REQUIRED FOR LOW LEVEL METALS ANALYSES?

For metals, typical minimum sample requirements are 20 mL for waters.  Larger volumes are recommended to allow for Quality Control samples and repeats.  A summary of sampling requirements is presented in Tables 1-2 below.

Table 1: Sample Collection – Ultratrace Metals

SAMPLING ELEMENT GROUNDWATER SURFACE WATER DRINKING WATER
Sample Container 50 mL HDPE 50 mL HDPE 50 mL HDPE
Field Filtered Yes No No
Preservative HNO3 (to pH <2) HNO3 (to pH <2) HNO3 (to pH <2)
Minimum Sample Size 20 mL 20 mL 20 mL
Recommended Sample Size 50 mL 50 mL 50 mL
Hold Time 180 days 180 days 180 days
Sample Container 50 mL HDPE 50 mL HDPE 50 mL HDPE
Dissolved Metals (filtered) Yes No No

Table 2: Sample Collection – Ultratrace Mercury

SAMPLING ELEMENT GROUNDWATER SURFACE WATER DRINKING WATER
Preservative HCl (to pH <2) HCl (to pH <2) HCl (to pH <2)
Minimum Sample Size 50 mL 50 mL 50 mL
Recommended Sample Size 100 mL 100 mL 100 mL
Hold Time 28 days 28 days 28 days

6. WHAT ARE ACCEPTABLE SAMPLE HOLD TIMES FOR SAMPLES SUBMITTED FOR LOW LEVEL METALS ANALYSIS IN WATERS?

As a rule, it is ideal to analyse environmental samples as soon as possible after collection to minimize any changes to the sample or the parameters of interest over time.  Maximum hold time for preserved samples submitted for ultratrace metals analyses is 180 days and 28 days for mercury.

Table 3: Reporting Detection Limits2 – Ultratrace Metals by ICP/MS3

PARAMETER RDL ug/L
Aluminum (Al) 0.20
Antimony (Sb) 0.005
Arsenic (As) 0.02
Barium (Ba) 0.02
Beryllium (Be) 0.01
Bismuth (Bi) 0.01
Boron (B) 5
Cadmium (Cd) 0.005
Calcium (Ca) 10
Cesium (Cs) 0.05
Chromium (Cr) 0.04
Cobalt (Co) 0.005
Copper (Cu) 0.05
Iron (Fe) 0.50
Lead (Pb) 0.005
Lithium (Li) 0.10
Magnesium (Mg) 5
Manganese (Mn) 0.03
Mercury (Hg)* 0.0002
Molybdenum (Mo) 0.01
Nickel (Ni) 0.02
Phosphorus (P) 1
Potassium (K) 10
Rubidium (Rb) 0.05
Selenium (Se) 0.04
Silicon (Si) 2
Silver (Ag) 0.003
Sodium (Na) 10
Strontium (Sr) 0.05
Sulphur (S) 500
Tellurium (Te) 0.01
Thallium (Tl) 0.005
Thorium (Th) 0.001
Tin (Sn) 0.01
Titanium (Ti) 0.40
Tungsten (W) 0.04
Uranium (U) 0.002
Vanadium (V) 0.03
Zinc (Zn) 0.01
Zirconium (Zr) 0.04

*Determined using cold vapour atomic fluorescence

7. ARE THERE SPECIAL SAMPLE COLLECTION PROCEDURES FOR LOW LEVEL METALS?

Yes.  With low level metals analyses, there is an increased risk of sample contamination from extraneous sources.  To address this risk, the United States Environmental Protection Agency (USEPA) published Method 1669, “Sampling Ambient Water for Trace Metals at EPA Water Quality Criteria Levels”4, referred to as the “Clean Hands/Dirty Hands” sampling technique.

As the nickname implies, “Clean Hands / Dirty Hands” sampling is a two-person task. One team member is identified as “Clean Hands” and the other as “Dirty Hands”, which reflects their roles and tasks associated with the sampling process. In other words the “Clean Hands” team member performs all activities requiring contact with the sample and sample container, sample collection, sample filtration and sample preservation.  The “Dirty Hands” team member is responsible for preparing any sampling devices (except the sample container itself), operating machinery, and all other activities that do not involve direct contact with the sample.


References

1 The filter media must be demonstrated to be free of metals

2 Reporting limits may vary and may not be achievable on all samples. Not all elements are routinely reported.

3 ICP/MS = Inductively Coupled Plasma/Mass Spectrometry

4 U.S. Environmental Protection Agency, Office of Water Engineering and Analysis Division, Method 1669: Sampling Ambient Water for Trace Metals at EPA Water Quality Criteria Levels, July 1996

ChemoAlert

ChemoAlert is a complete surface sampling solution, designed to make it easy for you to collect samples of HDs developed to help you achieve compliance with USP 800 for safeguarding healthcare workers. The kit contains everything you need to collect up to 10 samples and return them to our industry-leading laboratory for analysis, shipping included. Using the ChemoAlert kit’s step-by-step instructions, you can accurately evaluate HD surface contamination by having samples analyzed at our AIHA/ISO 17025 accredited laboratory.

1. CAN I USE THE KIT TO SAMPLE FOR A DRUG THAT IS NOT ON THE ChemoAlert LIST?

Yes, we have sampling and analytical methods for more than 1,000 drugs. Please let us know which drug you want to sample before placing your order, so that we can make sure that you have the correct sampling media.

2. WHAT ARE THE SAMPLING RESTRICTIONS FOR DRUGS THAT ARE NOT ON THE ChemoAlert LIST?

The sampling restrictions for drugs that are not on the ChemoAlert list may include:

  • Availability as a single drug target only
  • A 3-sample minimum order requirement
  • Sampling media restrictions, e.g. alternative swab or wetting agent
  • Handling, storage and shipping restrictions

3. DO I NEED TO REFRIGERATE THE ChemoAlert KIT WHEN IT ARRIVES?

The ChemoAlert kit itself does not have to be refrigerated. It does however come with a frozen ice pack, which needs to be placed in a freezer before sampling. Samples need to be returned to the laboratory with a frozen ice pack.

4. DO I HAVE TO REFRIGERATE THE SAMPLES THAT I COLLECT WITH THE ChemoAlert KIT?

If you are unable to send the samples back to us right away, they should be refrigerated. When you are ready to send them back to us, a frozen ice pack needs to be included with the samples.

5. DOES THE ChemoAlert KIT HAVE AN EXPIRATION DATE?

The ChemoAlert kit does not have an expiration date. If you are planning to keep the kit on a shelf for a while, please remember to place the ice pack in a freezer, so it is ready for when you need it.

6. IS THERE A MINIMUM ORDER SIZE FOR SAMPLES COLLECTED WITH THE ChemoAlert KIT?

There is no minimum order size for samples collected using ChemoAlert.How will ChemoAlert results be reported?

ChemoAlert results will be reported electronically via email, with a PDF file attachment sent to the email address recorded on the Chain of Custody form. Ask us about electronic data deliverables and benchmark/trend reporting.

IN SUMMARY

This bulletin lists some of the most frequently asked questions received by Maxxam regarding sampling and analysis with ChemoAlert. As technology advances and our knowledge surrounding the science of Chemotherapy drugs in the environment increases, new questions arise. For any enquiries concerning sampling and analysis for ChemoAlert, please contact Bureau Veritas’ expert below.

For more information, please contact:

Matt Meiners, CIH
Consulting Scientist
matthew.meiners@bureauveritas.com
847.726.3720
Pharmaceutical Industrial Hygiene Laboratory
95 Oakwood Road
Lake Zurich, IL 60047

ACTIVE PHARMACEUTICAL INGREDIENTS

Bureau Veritas offers highly sensitive and specific Industrial Hygiene sample analysis for air and surface samples collected for Active Pharmaceutical Ingredients (APIs), Isolated Process Intermediates (IPIs), as well as many process chemical agents and solvents. We don’t just provide analysis – we will be there to provide information and support, as well as sampling media which is included in the cost of analysis. Samples may be submitted for analysis “upon demand”, with a standard turnaround of 7 working days from receipt of sample submissions. Confirmation of sample receipt is provided by email, as well as the analysis report in PDF format upon completion of analysis. Expedited service is available for a surcharge, which must be coordinated with the laboratory in advance of sample.

1. HOW DO I GET INFORMATION ON AVAILABLE SAMPLING AND ANALYTICAL METHODS?

Search for the API or sampling target using the Bureau Veritas sampling guide. If an application is found, assess the details to see if it meets the requirements of your sampling plan.

If you do not find an available application, or the application doesn’t fulfill your needs, inquire with us to assess if a method is pending or other sampling options exist, such as semi-specific or nonspecific methods or if process surrogates may be an option.

2. WHERE DO I FIND EXPOSURE LIMITS FOR APIS?

Because of the wide variety of APIs and dynamics of the pharmaceutical industry, there are very few defined regulatory or published health limits (such as PELs, RELs, TLVs, etc.) available. This doesn’t mean you don’t need to worry about them, as they are regulated indirectly. Employers are required to provide their employees with a place of employment that "is free from recognizable hazards that are causing or likely to cause death or serious harm to employees." In the pharmaceutical industry, API Occupational Exposure Limits (OELs) are typically derived by the innovator during development, subject to refinement based upon toxicology and clinical testing. While they aren’t typically published, they can sometimes be found on the manufacturers SDS, or should be available from the commercial supplier of the material. If you are having difficulty finding a limit, contact us to discuss options for having one developed.

3. I NEED RESULTS URGENTLY! HOW CAN I EXPEDITE ANALYTICAL SERVICE?

  • Coordinate with our laboratory by phone or email prior to laboratory sample receipt
  • Specify when you need results on your submittal form, checking the box approving ASAP surcharges
  • Provide our laboratory with shipping details - tracking info or airway bill
  • Notify our laboratory of any schedule changes as soon as you are aware
  • Surcharges will be applied, and must be agreed to prior to sample submission

4. HOW CAN I GET SAMPLING MEDIA?

Sampling media is provided and included in the cost of analysis. It can be ordered online or through our Lake Zurich laboratory.

5. HOW DO I SHIP SAMPLES BACK TO THE LAB FOR ANALYSIS?

  • Short term storage and shipping conditions are specified by method
  • Use adequate and appropriate packing to protect samples during shipment
  • For International shipments:
    • Use a carrier with import/export authority and tracking systems (DHL or FedEx)
    • List samples as “air samples for analysis only” on all shipping documents, avoiding the use of API or chemical names
    • Limit the declared value of samples to a minimum “of no commercial value, assigned $xx USD for customs purposes”
    • Ship as “non-hazardous; not subject to TSCA, DEA, FDA or USDA control or restriction”

6. WHAT HAPPENS IF I SUBMIT SAMPLES ON THE WRONG MEDIA?

  • Our laboratory will review if the submitted media was evaluated during method development. If yes, and results were satisfactory, analysis will proceed and final report will indicate “non-conforming” media used in sampling. If the media was evaluated as “unsatisfactory” for your application, you will be notified that “analysis is not possible”.
  • If the media has not been previously evaluated, it will be at the option of the sample submitter to discard the samples, or request that the laboratory evaluate blanks and matrix spikes. If analysis is determined to be possible, analysis will proceed, and final report will indicate “non-conforming” media used in sampling.

7. HOW LONG SHOULD CAN I RETAIN UNUSED MEDIA, AND WHAT SHOULD I DO IF IT EXPIRES?

  • Bureau Veritas-supplied media is barcoded and tracked
  • Limit supplies to 60 days at US locations, or up to 120 days at international locations
  • Return unused or expired media to our Lake Zurich laboratory for media credit, barcode retirement and recycling
  • Most filter media expiration dates are assigned for media management purposes, not due to loss of efficacy for sampling. If you are considering using expired media, contact our laboratory
  • Sites with a significant negative balance of unreturned media will be invoiced at media replacement cost

 

For more information, please contact:

Matt Meiners, CIH
Consulting Scientist
matthew.meiners@bureauveritas.com
+1 847.726.3720
Pharmaceutical Industrial Hygiene Laboratory
95 Oakwood Road
Lake Zurich, IL 60047

SURROGATES FOR AEROSOL CONTAINMENT

Bureau Veritas offers highly sensitive and specific sample analysis for air and surface samples collected during process surrogate containment studies. We can assist you in selecting the best method for your particular situation, providing information and support, as well as sampling media and sample analysis. Samples may be submitted for analysis “upon demand”, with a standard turnaround of 7 working days from receipt of sample submissions. Confirmation of sample receipt is provided by email, as well as the analysis report in PDF format upon completion of analysis. Expedited service is available for a surcharge, which must be coordinated with the laboratory in advance of sample.

1. WHAT ARE MY SURROGATE OPTIONS?

By definition, any material which can be substituted for another in a process can be used as a surrogate if it meets the following conditions:

  • It behaves similarly to the material being substituted (both in the process and as an aerosol)
  • It does not adversely affect the process or equipment
  • There is an adequately sensitive sampling and analytical method available to measure it

Ideally, the surrogate will also be:

  • Readily available and inexpensive
  • Easily cleanable
  • Pose a low risk hazard to people, equipment and facilities
  • Pose a containment challenge equal to or greater than the material it is modeling

The most commonly used surrogates are: Lactose, Naproxen sodium, and Mannitol. Other common options include Acetaminophen, Riboflavin, Sucrose and Trehalose. The best surrogate option is a situational decision, depending upon a variety of selection drivers. Our Process Surrogates and Dusting Testing presentation outlines selection drivers and potential concerns for each of these surrogates.

2. HOW DO I GET INFORMATION ON SAMPLING AND ORDER SAMPLING MEDIA?

Sampling media is provided and included in the cost of analysis, and can be ordered online or by contacting our laboratory directly.

3. DOES BUREAU VERITAS PROVIDE BULK SURROGATE MATERIAL TO USE IN CONTAINMENT TESTING?

Bureau Veritas does not provide the surrogate for the test. If seeking gram quantities, they can be ordered from many laboratory chemical supply companies. For tests requiring Kg or higher quantities, acquisition through approved excipient suppliers of registered pharmaceutical companies is the best and most economical option.

For more information, please contact:

Matt Meiners, CIH
Consulting Scientist
matthew.meiners@bvlabs.com
847.726.3720
Pharmaceutical Industrial Hygiene Laboratory
95 Oakwood Road
Lake Zurich, IL 60047