In a recent blog post, we explored the steps taken to safeguard personnel who handle the potentially hazardous chemicals that are important elements in pharmaceutical preparation and testing. Some of these materials are toxic, flammable, or corrosive, but a CDMO has to be able to handle them.
We began by examining the procedural documentation and training steps a CDMO must take to ensure that its people know what they are dealing with and how to treat it – under normal conditions or if something goes wrong. But some of the most important protective measures can be literally designed and built into to the facilities and equipment. These measures include:
- Designated areas for hazardous material storage;
- Intrinsically safe electrical and lighting systems;
- Specially-designed fire suppression systems;
- Limited personnel access; and
- Specially designed airflow and ventilation systems.
When it comes to material storage, a warehouse area should be designed specifically to safely house hazardous materials. A CDMO facility serving a wide range of functions within the pharmaceutical supply chain must have explosion-proof features, as well as special fire suppression technology and containment systems designed to prevent chemical spills from spreading.
Designations for where various materials can be stored should be based on the International Building Code (IBC), which is very specific about what classes of materials cannot be stored in close proximity.
It should be a goal to make every employee fully aware when they enter a given location to know what is stored there. This can be accomplished with ongoing training and application of personal protective equipment to deal with those chemicals. Signage outside those areas can make it clear what is in that room, and what the restrictions are. A standard operating procedure (SOP) that explicitly diagrams where hazardous materials need to be stored can be written and posted so that everyone can see it.
Personal Protective Equipment (PPE) and special chemical handling equipment that must be employed with certain classes of compounds provide another layer of protection beyond the facilities design. PPE includes eyewear, gloves, protective clothing, and in some cases, full hood gear. Preparing pharmaceuticals can involve compounds that must be handled inside glove bags, or by operators wearing respirators.
To protect workers from exposure to certain gases, aerosols, or fine particulates, warehouse and lab employees must be skilled in the use of respirators or supplied air systems such as portable air tanks. Some of the equipment required for this work is cumbersome and uncomfortable to use, but a responsible CDMO will take its commitment to employ only people who understand the need for such precautions seriously and share that commitment never to be casual about the use of this equipment.
It goes without saying that much of this technology would be nearly useless without documented procedures and rigorous training, including:
- Material classifications and established containment bands defining where classes of compounds can be stored and handled;
- Handling and storage procedures;
- An active personnel training program; and
- Ongoing reviews – Equipment monitoring and regular maintenance, audits and inspections, and regular reviews of procedures.
Often, the service provided by a CDMO involves repetitive work, where team members are performing a familiar sample preparation or filling procedure time after time. Sometimes, however, clients may bring novel requests and new compounds to deal with. In those cases, the client should be prepared to consult closely with the CDMO to document safe handling procedures for its novel chemicals. And the CDMO must conduct ongoing safety training to meet changing customer needs without relaxing EHS standards.
Again, these tools help CDMOs safely manage important materials for the benefit of all involved – drug developers, manufacturers and, ultimately, the patients. Our EHS procedures are pervasive throughout Singota’s development, testing, aseptic filling, production and supply chain services.