OHSAS 18001 and Potent Compound Safety – Part VI.1

In Part V of this series on OHSAS 18001 and Potent Compound Safety I discussed Hazard Identification and Risk Assessment. Despite a somewhat extended absence due to out on the road serving clients, in today’s part, Part VI, I will be discussing identifying and implementing controls.

As most environmental, health and safety professionals know, the hierarchy of controls should be considered in the following order:

  • Elimination
  • Substitution
  • Engineering controls such as local exhaust ventilation, glove boxes, isolators, high containment valves, powders weighing hoods, and similar containment devices.
  • Administrative controls such as signage, procedures, job rotation, training, medical surveillance, and access control.
  • Personal protective equipment including respiratory protection, skin and hand protection, and face shields.

While in the biotechnology and pharmaceutical industry, the elimination and substitution of active pharmaceutical ingredients is difficult, it is possible by following modern day green chemistry principles to optimize processes to reduce steps in the process and eliminate the use of particularly hazardous process substances such as methylene chloride, carbon tetrachloride, sodium azide, chloroform and the like. Considerations for elimination and substitution should be made as early as possible in the development process since once the new drug application (NDA) has been submitted it becomes difficult to make process changes. While it is not impossible to make a change, it is just another hurdle to go over.

After elimination and substitution has been considered the next best choice for controlling potential exposures to potent compounds is the use of engineering controls. In the biotechnology and pharmaceutical industry, typical engineering controls can include, but not limited to, the following:

  • General room ventilation
  • Local exhaust ventilation such as snorkels, slotted ducts near points of charging or discharging reactors
  • Horizontal laminar-flow booths
  • Down-flow booths
  • Powders weighing hoods
  • Split butterfly powder valves
  • Bag-out waste disposal ports
  • Glove boxes
  • Hard-shell glove box isolators
  • Flexible containment
  • Rapid transfer ports
  • Engineered bags

When selecting the appropriate type of containment devices, a large number of factors must be considered. These factors are typically focused in the following areas: 1) material quantity and characteristics; 2) equipment characteristics; 3) degree of containment necessary; and 4) the amount and type of human interaction required. If you don’t have internal resources such as engineers and industrial hygienists, outside EH&S consultants can assist in the appropriate selection and design of engineering controls. Once engineering controls have been selected, appropriate vendors should be contacted to provide detailed specifications on the degree of containment that these devices will achieve. Most reputable vendors will have either white papers or reports that show the results of containment studies that have been performed using surrogate materials such as lactose or naproxen sodium. Some companies may go as far as requiring factory acceptance testing (FAT) to ensure that the containment device meets stated containment performance requirements. In any case, once a containment device has been installed at the customer’s facility, it is critical that containment validation be performed to verify that not only has the equipment been installed correctly, but also that operational procedures and work practices are performing as intended. In regards to OHSAS 18001, written procedures and documentation should be prepared and organized to demonstrate compliance with internal requirements.

Well, I’m over my 500 word limit, so I’ll break this section up into 3 subparts. In the next part I will continue on with a discussion on administrative controls. In the mean time if you have any questions please contact me at Affygility Solutions, or follow me on Twitter, or on LinkedIn.


About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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