Performance. Quality. Expertise. The PQE. All good words.

In the business of laboratory containment, Flow Sciences must achieve all three!

FSI’s containment expertise includes toxic chemicals, virulent microscopic entities, and highly potent pharmaceuticals. All these challenges require containment vigilance! To support our customers in their vital missions, FSI must provide the necessary PQE in every product we make!

FSI customers value these attributes for good reasons. Preserving employee health is very important to them. Sound research cannot happen without confidence in results. Purity of production is a prerequisite for pharma manufacturing. Flow Sciences has therefore emphasized PQE when conferring with our customers. It is our shared language.

In this paper, the writer will address all three words and measure their influence on our operations at Flow Sciences. We have already examined these terms separately in other published works (1, 2, 3, 4), and will do so in a more unified fashion here, using current examples.

Why PQE Are All Important:

  • Performance is a well-understood term in the containment industry. There is, however, some confusion in evaluating the term. Most of this fogginess comes from poor memorialization requirements for performance in job specifications. Frequently, specified definitions of performance pertain to details actually unrelated to worker safety. Instead, the chief concern in facility construction is focused on building sustainability, sometimes at the peril of researcher safety, even if this result is unintended.

Here is a typical example from an actual job specification of how deemphasizing worker safety in favor of sustainability can occur:

Job Specification

In this specification, both performance and sustainability appear to be equally emphasized. Fifty FPM at a full sash opening represents a very low face velocity, which should yield a low extract rate, optimal for sustainability based on less energy use. The containment “test” set forth in the specification appears rigorous, particularly with the jungle of boxes placed as specified (see above). A passing test should assure worker safety.

So….what’s the big deal? 

First, there is a limited capability for fume hood containment at such a low face velocity at full sash opening with the unrealistic and vaguely stated fume hood can/box challenges specified. This “example” does not even “block up” large objects, a frequently advocated technique used worldwide when bulky objects are inside a chemical hood. The illustrated obstacles eliminate the ability to place the ASHRAE 110 diffuser in its specified location. Also, the recommended set-up in Fig. 1 essentially nullifies any positive containment contribution from the fume hood baffle system.

Second, the inherent tension between sustainability (historically low face velocity) and worker safety (low pass-fail level unjustified by the literature) tends to corrupt job installation and certification.

Missing from the specified test description are the conditions of the test itself.  Is this a field test, a factory test, or something else, like an abandoned lab at the facility with a prototype hood (I have seen this). The fume hood “test” itself may wind up having nothing to do with facility airflow conditions or the processes undertaken inside the hood in the completed project.

Under these conditions, this fume hood “test” could become meaningless and irrelevant to any person not simply checking boxes on a punch list!

Even worse, third party field testers frequently feel pressured to cut corners and submit positive results to support job site on-time incentives. If a fume hood passes the “test” under a rushed scenario, construction continues unabated with all on-site parties blissfully happy.

Performance (i.e. worker safety) is the clear victim in such a scenario. Manufacturers, architects, and job supers must prevent such things from happening, especially when lab construction participants confront problematic sustainability requirements, “performance tests”, and “data” while time is of the essence.

A responsible containment equipment manufacturer should identify such specified tricky situations as the one described above and always insist on worker safety being the PRIMARY CONCERN in any lab safety device! Energy savings must be a lower priority. Performance should never be eclipsed by parsimony.

Containment product quality is an important requirement in any lab project. For such equipment, the following two factors are always present and should be measured and memorialized:

Documented QC controls that record production faults as well as changes in manufacturing designed to eliminate them. Such continually updated engineering records are the essence of ISO 9001:15 manufacturing procedures. Flow Sciences is on board with all of this.

FSI achieves demonstrable quality by defining our production materials and manufacturing methods, then verifying these things are present using ISO 9001:15, ASHRAE 110-2016, and the International Society for Pharmaceutical Engineering surrogate powder containment Protocols.                         

An internationally stable supply chain, which facilitates specification, compliance, and accuracy. No mixing and changing suppliers without identification and documentation! Obviously, this quality component has jumped several spots in importance based on our increased awareness of supply chain pressures present during the Covid 19 era. Even “big box” stores frequently cannot get toilet tissue or isopropyl alcohol!

Manufacturers can move toward more stable supply chains by identifying equivalent parts and incorporating them into engineering records before demand stresses occur. Two advantageous locations for memorialization of such alternate suppliers is in UL1805, the standard for fume hoods, and UL 508, which establishes requirements for control circuitry.

Once we achieve quality objectives, key components may be warehoused at the manufacturing facility or nearby to forestall crisis supply chain issues.

“Quality” in the above section is all about documenting the proper supplies and executing competent construction. This may surprise the reader. It should not. If performance and expertise exist in a design-manufacturing scenario, the quality steps outlined above may insure and represent both. 

Expertise means that a company’s representatives have the ability to understand customer needs and deliver the best and most appropriate solution. Even when a containment challenge is novel, engineers must have had experience successfully modifying current designs to deliver containment and function in related applications.

FSI is successful as a company because our people can do this for two reasons: great education and years of experience:

  • Great Education is at the root of a company’s ability to see, understand, and act upon data. FSI has two staff PhD’s, four Mechanical Engineers, and one Aerospace Engineer, all affiliated in some way with the design efforts of our containment products. Universities involved in these degrees include the University of Massachusetts, University of Illinois, University of California, Berkeley, University of North Carolina, North Carolina State University, Adelphi University, Rutgers University, Rochester Institute of Technology, and Northumbria University (UK).
  • Significant Experience compliments education. Our executive and engineering staff have a range of seven to thirty-five years of experience in our business. This expertise has led to our employees having their names on more than 18 patents. We hold or have held membership in SEFA6, NFPA7, ACS8, ASHRAE9, and ABSA10.

Drs. Haugen and Goodman frequently publish articles on our website, flowsciences.com, and present papers at national conferences such as I2SL and Interphex. In March of 2020, the American Chemical Society’s Publication Chemical Health and Safety posted a peer-reviewed paper by FSI on fume hood energy savings.11

For FSI, all this expertise has resulted in the successful completion of about one hundred fifty successful custom containment projects per year since 2018. Each of these projects consisted of at least one and as many as five custom components. We regularly review such custom products on our website and sincerely hope their successes will attract new customers to our company.

Summary:

FSI project components are high-performing pieces of laboratory equipment, not commodities.  They reflect quality and the expertise of our design and sales engineers. Briefly stated, they work!

In an era of highly active pharma ingredients, world pandemic, and infrastructure and supply chain pressures, who can ask for anything less! 12

References:

  1. Novel Techniques for Containment, Haugen, 2020, Flow Sciences Website Article, https://flowsciences.com/novel-techniques-for-containment/
  2. Virtual Showroom:Bulk Powder Containment, 2020, Haugen, Flow Sciences Website Article, https://flowsciences.com/flow-sciences-virtual-showroom-bulk-powder-hybrid-isolator/
  3. Bilk Powder Containment, 2020, Haugen, Flow Sciences Website Article https://flowsciences.com/bulk-powder-containment-key-factors-for-high-potency-handling-and-processing/
  4. Five Tests for Containment, Haugen, 2020, Flow Sciences Website Article https://flowsciences.com/five-tests-for-containment/
  5. 2013 Draft Fume Hood Specification, 2013, University of Wisconsin, Section B1.7
  6. Scientific Equipment and Furniture Association
  7. National Fire Protection Association
  8. American Chemical Society
  9. American Society of Heating, Refrigeration, and Air Conditioning Engineers.
  10. American Biological Safety Association
  11. Laboratory Hood Energy Savings: The Low-Hanging Fruit, Robert K. Haugen, ACS Journal of Chemical Health and Safety, March 2020
  12. Variation on a Theme by George Gershwin, I’ve Got Rhythm, 1930, Chappell Music, Ltd.