Four process closure benefits for a company
The term “closed process” in process manufacturing is often thrown around without understanding the salient issues. Process closure can certainly provide many benefits, but there are various impacts and requirements depending on the ultimate goal and the specific process a company is trying to close.
A crucial distinction with respect to building codes needs to be made regarding a closed process. It means something different than it does in terms of Current Good Manufacturing Practice (CGMP) standards.
If there are flammable liquids or vapors in a facility, fire and building codes will define the 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.
CGMP standards dictate closed processing is required for some pharmaceutical product forms to protect patients. The contamination risk is higher for drug products that are injected than for those that are ingested. Therefore, the injectable product process must be rigorously protected through closed operations.
Beyond this distinction, there are business considerations in the closed versus open debate. A company needs to ask what they’re trying to achieve when they decide to close their process.
The four “P’s” of process closure
There are four ways closing a process can positively impact a 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 the company’s bottom line. Conversely, closing your process can reduce capital investment in a facility. However, it may add equipment costs.
- People: Closed processing provides safer conditions for operators. This is especially true for environments where workers can be exposed to hazardous vapors, liquids, or toxic and potent compounds.
- Perception: Potential customers or clients viewing a company’s facility may gain confidence in an operation by how the 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. Perception can drive sales, especially in the case of contract manufacturing.
- Product: Pharmaceutical products are at risk of contamination during processing and packaging. Different closure levels are required depending on the product type and the patient delivery pathway. Dedication to product purity is all about ensuring patient safety.
An integrated, multi-discipline team can help pharmaceutical facilities navigate the nuances of closed versus open processing.