While finished drug products are intended for eventual human consumption, many of the raw materials and chemicals used to make these products require special safety considerations. Some of these materials are toxic, flammable, or may be corrosive. So, it’s essential to a CDMO’s mission that it can handle some intense stuff.
There are several key tools that a CDMO uses to do this. For example:
Facility and Equipment Design
- Designated areas for hazardous material storage
- Intrinsically safe electrical and lighting systems
- Special fire suppression systems
- Limited personnel access
- Specially designed airflow and ventilation systems
Personal Protective Equipment
- Eyewear, gloves, protective clothing, full hood gear
- Respirators, supplied air systems
- Glove boxes and glove bags
- Chemical hoods
- Single use containers and supplies
- Material classifications and established containment bands
- Handling procedures
- Storing materials properly, keeping reactive materials away from one another, etc.
- Active personnel training program
- Equipment monitoring and regular maintenance
- Audits and Inspections
- Reviews of procedures
These tools help CDMOs safely manage important materials for the benefit of all involved – drug developers, manufacturers, and ultimately, the end patients.