A Specialized Pharmaceutical Kit Assembly Solution
Historically, kit assembly at our commercial US facility was a manual packaging process with 200% manual verification to ensure quality adherence. This process was and still is efﬁcient for niche/orphan projects which are high value, small volume, but when a strategic client partner requested that Almac launch their large volume, Insulin injector pen pharmaceutical kit onto the US market, we promptly added a semi-automated packaging system to meet their launch timelines and the high market demand.
The design concept
Building upon the existing quality led commercial packaging offering provided from Almac’s US facility, the new SAPS technology was designed to provide an innovative solution to meet customer needs for efficient complex kit assembly of medical devices, combination products and biologic packs.
The design of the SAPS line was derived from one of Almac’s specialist business project teams that comprized of subject matter experts from packaging design, production, engineering, technical quality and quality assurance.
From the initial meeting, the multi-disciplinary team defined the following key requirements:
Flexibility was one of the key factors that prompted Almac to develop this bespoke solution in-house rather than purchase an ‘off-the-shelf’ piece of technology. The SAPS line was designed to operate to various scales. Having up to 18 work stations on the line facilitates processing a variety of pack formats from sample kits to marketing packs as well as multi product dosage packaging. In addition to the work stations being highly customizable, we have ensured the SAPS technology can meet all our current and future client needs.
2. Quality assurance
With quality compliance and kit completeness of upmost importance, the new technology was designed with 100% automated inspection and rejection of each component in mind. The multiple, strategically placed vision inspection systems on the SAPS technology not only provides automated component checks, but also verifies variable data correctness including color recognition.
3. Time efficiencies
One key requirement of the design specification was to create a piece of technology that reduced human input to provide a more time efficient process with a high throughput rate to have the required capacity to meet large commercial-scale, high-level market demand.
With all new business projects within Almac, a multi-disciplinary team of subject matter experts was formed. The team developed a User Requirement Specification (URS) document, which provided a benchmark to evaluate readily available technologies against. Upon the evaluation process, the team concluded that there wasn’t a suitable ‘off-the-shelf’ solution available, resulting in Almac’s specialist in-house engineering team being commissioned to create a bespoke piece of technology.
From project initiation, technology design, build and qualification to processing validation batches, we successfully launched our client partners’ drug product in a 6 month timeframe. Fig. 1
The installation of a semi-automated secondary packaging line in our US commercial packaging facility for complex kit assembly was in Almac’s capital expansion plans for the coming year, but when a key strategic client partner approached us to launch their injector pen pharmaceutical kit, the timeframe was expedited to ensure we met our client’s needs.
With a launch date as the end time point, Almac had to ensure all key milestones were met and the SAPS technology was commercially ready ahead of time. With a 6 month timeframe for build through to validation, one major challenge was the lead times of the various components for the line that was controlled by the various vendors.
2. Undefined pack design and artwork
Building the bespoke SAPS technology alongside ensuring it was ﬂexible to meet the undefined packaging of its ﬁrst commercial pharmaceutical kit presented an additional challenge.
One of the key features of the SAPS technology is its automatic vision inspection systems. When the line was being designed, built and qualified, test components were being used. These test components had black and white artwork, so the initial electronic compliance verification tests were completed in grayscale. This posed a further challenge to the project team as the artwork of the clients’ pharmaceutical kit was only ﬁnalized one month prior to launch meaning that the vision inspection software used for previous testing had to be reconﬁgured to verify colored packaging components.
Keys to success
1. In-house capabilities and expertise
Having specialist in-house engineering and pack design teams, coupled to input from key departments such production, ensured that the SAPS technology was designed and built with not only functionality in mind but also processability to provide a fully ﬂexible complex kit assembly solution for multiple pack formats.
Utilizing Almac’s in-house engineering and pack design expertise facilitated a rapid turnaround of the bespoke SAPS technology, delivering an industry-leading complex kit assembly solution.
2. Strong client and supplier relationships
Having strong relationships with both our client partner and vendors helped to overcome some of the above challenges. The project team were in regular communication with both and the close working relationships allowed for open and honest discussions to anticipate and pre-empt areas for concern and address issues as they arose. Working closely with the local vendors helped to condense lead times for line components therefore keeping the build of the SAPS technology on track.
3. Project management and team work
Fundamental to the success of designing and installing the SAPS technology and successfully launching our clients’ drug product, was the coordination and management of all activities by Almac’s experienced Business Project Manager and Product Supply Manager who together led the expert multi-disciplinary team.
Given the short 6 month timeframe, the delivery of this bespoke piece of equipment to meet the clients launch date was only achievable with the dedication of the team and their strong work ethic to ensure the project was delivered on time.
In 6 months and within the projected budget, Almac overcame all challenges to design, install and qualify a bespoke commercial scale secondary packaging line to facilitate semi-automated complex kit assembly.
The investment and rapid installation of this new SAPS technology demonstrates Almac’s commitment to not only building long-term, strategic relationships with our client partners, but also our dedication in continually investing in and expanding our capabilities to deliver a best-in-class service. This will ultimately better serve our clients and patients, thereby maintaining our position as a global leader in the life sciences sector.