Training in Three Continents: Upcoming TrainingUTC

Dublin, Ireland | October 22 - 23, 2019

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Frankfurt, Germany | November 4, 2019

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Shanghai, China | November 22 - 23, 2019

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SafeBridge Potent Compound Safety "Boot Camp"® I
San Diego, CA | December 3 - 4, 2019

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San Diego, CA | December 5, 2019

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Can You See Five Picograms on a Filter?IHU

The SafeBridge analytical laboratory continues to develop the most sensitive methods in the industry for analyzing active pharmaceutical ingredients (APIs) for industrial hygiene purposes.

In May, the laboratory successfully validated an industrial hygiene air sampling and analytical method with improved analytical sensitivity for measurement of naproxen sodium on filters. SafeBridge's laboratory can now quantify naproxen sodium collected on air sampling media at levels down to 5 picograms per filter. This limit of quantification is ten (10) times lower than methods available from other commercial laboratories.

With this improvement in sensitivity, naproxen sodium can now be measured at airborne concentrations as low as 0.1 nanograms per cubic meter (ng/m3) for 15 minute tasks. This creates an effective tool for organizations involved in handling hazardous materials in powder and liquid forms to verify that controls can achieve the low Occupational Exposure Limits (OELs) and Containment Performance Testing (CPTs) for highly toxic or potent compounds.

For further information please contact: Kent Rader, Manager, Analytical Laboratory Business Development at 650-237-9969 or by e-mail at

The EN 689 standard was first established in 1996 and is intended for use in the analysis of industrial hygiene data sets across all industries. Although not widely used in the United States, it has become a common approach in the analysis of industrial hygiene or containment performance test data in the pharmaceutical industry. For example, the International Society for Pharmaceutical Engineering (ISPE) references the 1996 version of the standard in "Assessing the Particulate Containment Performance of Pharmaceutical Equipment" (ISPE, 2012). A new version of EN 689:2018 was published in 2018 and some companies and vendors have started to apply this version to containment performance testing results. So what is the difference between the two versions and should you be following this standard?
Under EN 689:1996, where fewer than three data sets of containment performance data are available, the results are judged acceptable if they are all less than 10% of the containment performance target (CPT); note that the CPT is typically set at the occupational exposure limit (OEL). Where three sets of data are available, the following criteria should be applied to decide if the data is "acceptable", that is, the data give us confidence that the CPT is not normally exceeded:
  • Three (or more) sets of results are all less than 25% of the CPT, OR
  • All results are less than 100% of the CPT and the geometric mean of three results is less than 50% of the CPT.
SafeBridge's experience and statistical analysis has shown that when the EN 689:1996 criteria are applied and met, then there is a high probability that airborne concentrations won't exceed the CPT if the equipment and work practices are maintained.
EN 689:2018, however, has adopted a more conservative approach to data analysis. Under the 2018 version, a data set is considered acceptable if the following criteria are met:
  • Three sets of results are all less than 10% of the CPT, or
  • Four sets of results are all less than 15% of the CPT, or
  • Five sets of results are all less than 20% of the CPT
If all results are less than the CPT but these criteria are not met, then a further statistical test should be applied.
So should you be applying EN 689:2018 to your containment performance data? In most countries, including the United States, there is no requirement to use this standard, and the ISPE still references EN 689:1996. So, it is really a question of the level of confidence desired as well as your ability to collect enough data to demonstrate acceptability under the standard. A containment device that meets the 2018 criteria is very likely to keep exposures below the CPT. However, when applying EN689:2018 to containment performance data, many of the operations that "fail" may actually not be at risk of exceeding the CPT. That is, applying the more stringent 2018 criteria can often result in apparent failures to achieve the required containment performance for containment devices that are actually acceptable. A large number of further data sets may then be needed, according to the 2018 approach, to determine acceptability for operations.
SafeBridge continues to recommend a rule-based approach such as EN 689 in the analysis of small data sets (fewer than six data points from a given SEG), or highly censored data sets where most of the values are below the limit of quantification. Rule-based data interpretation is easy to use, is "black and white", and often allows better decision making than calculating traditional statistics or Bayesian statistics, since the estimated statistical distributions using these methods can often be misleading for small data sets, particularly for log-normally distributed data. However, the choice of which rule-based approach to apply, and whether it should be EN 689:1996, EN 689:2018, or another approach can depend on many factors including a risk assessment for your specific operation(s).
For more information on the application of EN 689 or on the statistical analysis of industrial hygiene and containment performance test data, please contact SafeBridge at (650) 961-4820 or via our website

Come See SafeBridge At These Upcoming TradeshowsUTS

Eurotox Summit
Finlandia Hall | Helsinki, Finland | September 8 - 11, 2019
Chris Seaman will be attending. 

Eurofins Extractables and Leachables Symposium 
Boston, MA | September 19, 2019
Allan Ader will be attending and presenting "Appropriate Scientifically-Defensible Approaches to Assessing the Toxicity of Extractables and Leachables in Drug Products: Using All the Tools Available".

Society for Chemical Hazard Communication
Crystal Gateway Marriott Hotel | Arlington, VA | September 21 - 25, 2019
Joe Morehart and Michelle Myers will be attending on behalf of the Redstone Group.

American Pharma Outsourcing Summit
Sheraton Philadelphia Downtown Hotel | Philadelphia, PA | September 23 - 24, 2019
Allan Ader and Janet Gould will be attending. Allan will be presenting "Lessons Learned from the Outsourcing of R&D and Manufacturing of Potent APIs and Drug Products: Worker Safety and Product Safety Perspectives".

Meet Our Newest Certified Industrial HygienistCIH

Congratulations to Lily Fry!

Lillian Fry, CSP, CIH has become a Certified Industrial Hygienist (CIH). SafeBridge now has seven CIHs on staff. Lily has almost 10 years of experience supporting companies in recognition, evaluation and control of drugs and drug products. She has conducted many qualitative and quantitative assessments of worker exposure potential in the pharma and biotech industries. 

SafeBridge Strengthens Their Laboratory TeamNSM

Sean Tang has over 20 years of experience in analytical and bioanalytical analysis.  Before joining SafeBridge Consultants in April of 2019, he was a senior scientist at a medical device startup company where he developed H/UPLC, SDS-page, and dissolution methods for formulation study and biological, drug, and medical device combination finished products in a cGMP environment. His previous positions include senior chemist and lab director in analytical CRO laboratories, conducting HPLC, LCMSMS, SDS-page, and ELISA method development and sample analysis (R&D, GLP, GMP) for pharmaceutical companies and the hygiene industry. Prior to that he was a researcher at Chengdu Institute of Biology, Chinese Academy of Science, where his work included developing TLC, IR, HPLC, LCMS method for peptide characterization and methods for biodegradable polymer extraction from cell culture, purification, characterization, and analysis.

NYC Office MoveNYCM

The NYC office moved from the 11th floor to the 9th floor in June, and are up and running in their shiny new digs! While they still have some unpacking and decorating to do, the office is coming along nicely! The new office has a beautifully modern kitchen and tons of natural light. The NYC staff are extremely happy in their new offices and are putting their own personal and creative touches into their space.

Future SafeBridge All-StarsFSB

Congratulations to Stephen Nowakowski, in our Pennsylvania office on the birth of his beautiful baby girl, Mae Nowakowski. Mae was born on May 3rd, at 5:44 AM, and weighed 6 pounds 6 ounces. Mom, baby, and Stephen are all doing great!

Congratulations Stephen!

Congratulations to Yana Chervona, Ph.D., DABT in our New York office on the birth of her beautiful baby boy, Julian Wyatt Perazic. Julian was born on June 6th, at 2:39 PM, and weighed 7 pounds 7 ounces. Mom, baby, Dad Enzo, an Big Brother Tristan are all doing great!

Julian will be the next DABT to join the SafeBridge team.

Congratulations Yana!

SafeBridge Consultants, Inc.
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Allison McCarthy
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212.727.0717 x 2407
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