When to close your pharmaceutical process
Too often, the term “closed process” is thrown around without an understanding of the salient issues. Pharmaceutical process closure can certainly provide many benefits, but there are various impacts and requirements depending on the ultimate goal and the specific process you are trying to close.
First, let’s make a crucial distinction: a closed process with respect to building codes means something different than it does in terms of CGMP standards.
If there are flammable liquids or vapors in your facility, fire and building codes will define your process as closed or open. It’s the former if liquids and vapors are in closed vessels and operating below 15 psig processing pressures at all times. The process is open if it operates above 15 psig, or the liquid and vapors cannot be contained. This difference has implications for electrical classification and other building and facility design features.
Alternatively, CGMP standards dictate that closed processing is required for some pharmaceutical product forms to protect patients. The risk of contamination is higher for drug products that are injected than for those that are ingested, for example. So the process for injectable products must be more rigorously protected through closed operations.
Beyond this distinction, there are business considerations for pharmaceutical process closure. When you decide to close your pharma process, what you are trying to achieve? Are you primarily protecting profits, people, product or perception? All of these are valid, but your main goal will drive your approach.
The four Ps of process closure
Here’s how closing your process can positively impact four different aspects of your business:
- Profits: Open handling of flammable materials often necessitates a more stringent building type, additional HVAC considerations, more expensive building materials, and construction, which cuts into your bottom line. Conversely, process closure can reduce your capital investment in your facility, but may add cost to your equipment and impact the ease of operation of your process.
- People: Closed processing provides safer conditions for operators in environments where they could be exposed to hazardous vapors, liquids or toxic and potent compounds.
- Perception: Potential customers or clients viewing your facility may gain confidence in your operation by the look of a facility. Closing the process can minimize free dust, improve overall housekeeping and can signify an appropriate culture for manufacturing goods even if the product or codes do not require such a closure. Especially in the case of contract manufacturing, perception can drive sales.
- Product: Pharmaceutical products are at risk of contamination during processing and packaging. Depending on the type of product and the ultimate patient delivery pathway, different levels of closure are required. Dedication to product purity is all about ensuring patient safety.
This only briefly covers the complexity of the question “closed versus open?” An integrated, multi-discipline team can help pharmaceutical facilities navigate the nuances of closed versus open processing. Through the International Society for Pharmaceutical Engineering, National Fire Protection Association and other organizations involved in the pharmaceutical and related industries, CRB has helped to establish standards covering these significant operational and patient safety issues.