A contract development and manufacturing organization for pharmaceutical companies will transport, store, test, process, fill, and package many different chemicals. While a drug company’s products are intended to treat human beings, not all of the chemicals used to make those products are safe for people to consume, or even to be around.
Before a new chemical is brought into the facility, it is important to work closely with the client to evaluate the material from an environmental health and safety (EHS) perspective. This starts with a look at the Safety Data Sheet (SDS) for Occupational Exposure Limits (OELs). Then, evaluate whether it represents a toxic, flammable, corrosive or any other type of hazard.
Some of the materials clients ask us to handle are so new in the drug developmental process that complete SDS with full OEL information has not yet been prepared. In these cases, special effort in developing a monograph is required. This is done by the drug developer’s scientists through direct testing of the compound, or by a chemical safety consultant who can look at the molecular structure and make comparisons to other, more familiar materials and draw conclusions about its safety aspects. The issue is not just whether we can handle the compound during normal operations; one needs to consider how one will deal with an emergency situation such as an unfortunate spill. Like any responsible CDMO, we may decline to handle some materials we deem unsafe for our facility.
The more hazardous the chemical, the greater the precautions we need to take. To organize our procedures, we group compounds of comparable risk into “containment bands,” representing the level of care we take in handling. Singota’s containment bands were adapted from a table developed by SafeBridge, a pharmaceutical consulting firm focused on the safe handling of chemicals.
Affytrac software (Affygility Systems) is a commercially available risk analysis system used to determine the risk one may encounter when handling a potent material. Information about the chemical, handling duration, engineering controls and personal protective equipment (PPE) is entered into the system by the personnel working with the particular material. The Affytrac program output will indicate potential risk levels. Accordingly, engineering controls and PPE are prescribed for handling that material.
Once this safety analysis has been completed, the material is “logged” into a database accessible to all of the team at Singota, so that if they encounter an unfamiliar chemical, they can quickly look it up to make sure it is properly stored and determines how it needs to be handled.
Singota has an 11-member safety team in place so that, at all times, we have people here who can handle a chemical spill, or any other environmental safety situation. That team meets regularly, so we have opportunities to train everyone when a contract requires us to store a new compound that requires special handling. It’s also important to continually evaluate safety systems and procedures. For example, Singota recently performed testing in its bulk chemical sample and dispense operations using a surrogate material to test exposure levels using our current SOP’s. This self-evaluation helps ensure that the containment bands and associated engineering controls are effective and reasonable based on OELs. The testing was completed by a third party industrial hygienist and reviewed by another third party.
Anyone at Singota who is about to handle a potentially hazardous chemical is required to pull out its SDS and review it. The SDS reminds them of the inherent risks associated with the compound. They can then consult the Affytrac database that measures those risks against the precautions we have built into our chemical handling procedures.
But safety is not an isolated function to a few persons within a company. Everyone should understand their roles in this important function. Everyone benefits personally from a strong commitment to EHS, and all understand that our clients trust us with the custody of hugely valuable assets.
Some of the more interesting challenges arise, however, from the understanding that the employee health impacts of exposure to certain chemicals may not be immediately obvious. We have to protect ourselves from chemicals that may not produce symptoms for several years after exposure.
Our EHS procedures are pervasive throughout Singota’s development, testing, aseptic filling, production and supply chain services. Our people are extensively cross-trained; our goal is to ensure that anyone who handles chemicals can handle the full range of compounds our clients store with us can do so safely.