It is critical to have the correct candidate with the right aptitude for BSC certification. Our experience has shown that candidates with math and some basic mechanical skills fare well in the training process. English proficiency should be considered as it allows for understanding and comprehension of training materials and BSC manuals, and it helps in the written and oral examinations. As a high school diploma (or equivalent) is a requirement for NSF 49 BSC field certifier accreditation, this too is essential. Having several candidates train at the same time allows them to support one another and work through problems together.

Ongoing responsibilities need to be considered when selecting candidates. Both laboratory scientists and biomedical engineers have participated in our program. For the engineers, this was an extension of their current work responsibilities, and there have been no issues. For laboratorians, consideration was not given to career path, and problems have arisen as to how the time away from laboratory duties will affect long-term advancement.

Our program mandates that BSCs be certified by accredited individuals to verify the required personnel, product, and environmental protection requirements. The accompaniment of all trainees by an accredited certifier allows students to develop and validate their skills through one-on-one instruction. This approach also provides immediate troubleshooting, repair, and problem-solving assistance through the greater experience of the mentor.

In Thailand, we were fortunate to have the cooperation of the one in-country NSF-accredited certifier from our collaborating partner at USAMC-AFRIMS. For the Cambodian program, we used our newly qualified NSF-accredited certifiers from Thailand as mentors, traveling with the trainees quarterly to certify BSCs for 2-week stints. These mentors do not have a broad range of experience, so ongoing advice and training were supported by an ABSA International registered biosafety professional (S.B.) from MORU, Thailand.

The model we use divides the training program into 2 formal courses (basic and advanced), with a minimum of 12 months in between, during which students practice their newly acquired skills from the basic training. To date, the Eagleson Institute (Sanford, Maine; affiliated with The Baker Company) has been our primary training provider (http://www.eagleson.org/complete-schedule), as all instructors are NSF 49-accredited engineers with many years of hands-on design, manufacturing, testing, and troubleshooting experience. In addition, they provide an individual mentoring service for the students immediately after both weeklong classes; these are offered twice a year.

Other companies do offer BSC training services in the United States, including Agape Instrument Services, Labconco Corporation, Thermo Fisher Scientific, and NuAire (http://www.nuaire.com/products/training.html). More regionally, training courses are conducted at ESCO’s headquarters in Singapore at their Demonstration and Training Facility (http://www.escoglobal.com/support/training-courses-and-seminars/78/). However, Singapore is not our primary training facility as they do not offer mentoring classes. We do use this facility for our repeat NSF practical examinations.

The first training is basic and offers an introduction to certification and the use of BSCs. Students learn to triage BSCs for problems and perform the primary certification tests. Instruction is a combination of lectures, discussion, problem-solving activities, and hands-on certification laboratories. The course focuses on Class II Type A2 BSCs, the most common BSC type in Southeast Asia.

After the completion of the basic training, students return to their facilities and practice their new certification skills, completing a certification report for each BSC tested. One year of practical experience from the date of the basic course is required to meet NSF BSC accreditation criteria.

Subsequently, students return to the United States for the 5-day advanced course at Eagleson Institute, followed by another week-long mentored practical application workshop. During this time, trainees gain in-depth information and refine their practical BSC certification skills. This course includes certification of Class II Type B BSCs. Additional content is added depending on the problems the students confronted while certifying BSCs in-country.

Because of the specialized knowledge required for proper and safe BSC certification, NSF International administers an accreditation program for field certifiers. To become accredited, 3 obligations must be met: (1) a passing score of ≥80% on the written examination; (2) ≥90% score on primary and at least 70%on secondary practical tests; and (3) candidates must sign an ethics statement. Continuing education and periodic reexamination are required to maintain accreditation.⁵

The NSF accreditation examination is not mandatory for individuals taking the advanced class, but Eagleson does coordinate the written and practical examinations at the end of the advanced class for qualified individuals. To be eligible, the person must have proof of a high school diploma (or equivalent) and either completed a training course on BSC certification with evidence of active field certification through the submission of 20 test reports, 5 of which must be for Type B BSCs, or at least 3 years of field experience shown through submission of 10 reports per annum, with 2 being from B1 or B2 BSCs.

The written examination is 3½ hours long and covers field certification, instrumentation, testing procedures, troubleshooting, and NSF standards/policies. It comprises 120 multiple-choice questions, each with only 1 correct answer. During the examination, the applicant may access NSF/American National Standards Institute (ANSI) standard 49 and program policies.

The practical examination entails the evaluation of Type A and B BSCs, covering both the primary tests (downflow velocity, inflow velocity, high-efficiency particulate air [HEPA] filter leak, cabinet leak, airflow smoke patterns, and site installation) and secondary tests (vibration, noise level, and lighting intensity).⁶ Instrument calibration and operation are also evaluated. Each test has a time limit, with a maximum of 9 hours for the full examination. Test equipment with current calibration documentation is provided by Eagleson so trainees need not travel with 70 kg of excess baggage.

We have recently added fumigation training to our program to expedite repairs, minimize costs, and provide sustainable practices. Typically, fumigation is required when a nonfunctioning component (such as a HEPA filter), located in a potentially contaminated plenum area, requires replacement. Primary methods for BSC decontamination are formaldehyde gas, vapor phase hydrogen peroxide, and chlorine dioxide gas.⁷ The decision was made to use the formaldehyde system as it was inexpensive with regard to equipment and consumables, and purchase is not restricted in Southeast Asia despite the fact that it is an Occupational Safety and Health Administration (OSHA)-classified carcinogen. This required that appropriate respiratory protection be purchased for all trainees (Table 1) and that they be fit-tested and given respiratory protection training. This was provided by an ABSA International registered biosafety professional (S.B.) with many years of experience and included monitoring of formaldehyde levels, validation of the decontamination process, and correct use of personal protective equipment.

The essential equipment used to determine the performance of the BSC in the 6 primary tests necessary for certification is detailed in Table 1. The total investment was approximately US $34 000 for each set of equipment purchased. Additional equipment for secondary, optional testing (measuring noise, vibration, and lighting levels in the BSC) ensures a comfortable work environment. If certifiers are involved in BSC relocations, then it is recommended that appropriate lifting devices such as flat woven wire slings and scissor lifts be purchased. These allow for easy positioning of the BSC between their stand and floor level. Secondary and additional equipment costs are about US $6500.

Mobile applications and web-based subscriptions are available that provide invaluable information for BSC certification. The Controlled Environment Testing Association (CETA) Spec Guide (http://www.cetainternational.org/content/ceta-products) includes airflow specifications, HEPA filter, motor, and bulb sizes for all major international manufacturers of BSCs, information that is required for certification. The guide is updated regularly, adding new models and changes in specifications. A subscription is currently $119.99/annum. The information in this guide is generally available in the BSC manual provided by the manufacturer, but this is often not available in the laboratory at the time of certification.

Software products such as Cert-Pro (http://www.cert-pro.com/) support field testing of BSCs, fume hoods, and clean-rooms, allowing for automation of the process by facilitating direct collection of data from instruments and automatic production of a certification report upon completion. Software costs around US$4500.

Expenses incurred for the basic and advanced workshops are detailed in Table 2 and are accurate as of January 2016.

Highly specialized, expensive equipment is needed to perform certifications (Table 1). As part of our sustainability plans, equipment was purchased and donated to the respective institutes for their use. Discussions on implementing a certification program were needed regarding the ongoing expenses in maintaining this service. The budgets developed included the cost of replacement parts and HEPA filters. Until institutional information is available, we have budgeted for a filter failure rate of 10% of BSCs certified annually.

To ensure equipment performance (and maintain accreditation), annual calibration and general maintenance are required. This may not be available in-country, so expenses (along with shipping charges) need to be considered (Table 1). Further consideration should include travel and per diem of staff if a regional program is implemented. For air travel, excess baggage for approximately 70 kg of equipment is needed.

Certifiers should also have access to petty cash for purchasing small items and consumables for service requirements during certifications. Without this, another layer of difficulty is added to achieving a timely outcome.

Our certifiers have developed materials outlining the certification process that are shared with the laboratory manager several weeks prior to their arrival. This document details why BSCs need to be certified, when this should happen, and what preparation is needed prior to the certifier’s arrival. The documents clarify the process for management and emphasize that certification does not include the repair of the cabinet, clean bench, or fume hood. All materials have been translated into the local language to ensure the information is understood.

During visits to different laboratories, it was clear that many staff had not been trained in the correct use of BSCs. While it is important that the BSCs operate safely, the individuals using them also need to be trained. As a routine part of each certification, the certifiers provide training in which they briefly describe the operating characteristics of BSCs, show how to correctly use them, and demonstrate the main maintenance operations. Training materials have been developed that include videos, presentations, job aids, standard operating procedures, and hands-on instruction.