1. Have you confirmed fill-finish compatibility?
A growing number of filling vendors see an opportunity in the market for fill-finish solutions that require minimal design input. Pre-designed modularized isolators with manual, semi-automatic or automatic fillers are emerging. Each can accommodate a different quantity range and size of vials. This trend allows a client and design group to quickly determine design parameters with a reputable vendor for the purpose of procurement. The design process after purchase still requires time, however, some of the filling options have fewer variables and possible design changes allowing for a more condensed timeline.
One of the downsides of these smaller fillers is they are typically less customizable in 3 main areas:
- Lack of advanced technology, such as continuous weighing/monitoring of drug products during filling. This limits one’s efforts to optimize the fill-finish process down the road.
- Future adaptability is usually severely limited.
- The compatibility of primary packaging—vials, stoppers, and seals—can also be limiting.
2. Have you factored in long lead times?
Although filling in the ATMP industry takes place on a smaller scale than for other drug categories, it does not mean that design decisions are any less critical. Equipment and primary packaging decisions must be made early so that the building can become operational soon after completion. Lengthy critical design decisions can create misalignment with the completion of the facility and the filling equipment on-site arrival, installation and qualification.
Persistent supply chain challenges plague the industry. A 45 to 70-week lead time for ready-to-use (RTU) components and primary packaging (including vials, syringes, stoppers, seals) can cripple a planned operation. Materials such as vials, syringes, stoppers, and seals need to be provided to the equipment manufacturer early in the design and at subsequent points in the design all the way to the factory acceptance testing (FAT). Missing design milestones within the equipment production schedule can lead to increased lead time, un-tested change parts, or missing fill line capabilities when the equipment arrives on site.