Jan Deininger: Highly specialized products in small quantities and different drug delivery systems – the trend for flexibility – present a challenge for pharmaceutical companies. It requires a change in thinking, since niche products require a completely different production process than Blockbuster pharmaceuticals. Pharmaceutical companies that produce small quantities need flexible machines that can process small batch sizes and different container types. At the same time, it is essential to maintain the high level requirements for product quality and patient safety.
As a result, the demands on the flexibility of the system are increasing. Smaller batch sizes have to be mastered and different containers such as syringes, vials and cartridges have to be filled on a single line. In addition, customers expect to receive all technologies from a single partner and benefit in particular if the systems are already put into operation at Optima Pharma.
CP: What capabilities do clients look for?
JD: Our customers expect solutions to the challenges described above. Optima Pharma has adapted to this at an early stage and made the realization of turnkey solutions its core competence. Optima Pharma develops and implements complex systems with the technologies filling and closing, isolator technology and freeze drying in central responsibility. This includes digitized planning, integrated Factory Acceptance Test (iFAT), site management, Site Acceptance Test (SAT) and comprehensive services. The latest engineering technologies such as flow visualization are used.
The Comprehensive Scientific Process Engineering (CSPE) method is used to ensure that as little time as possible elapses from order to start of production. The combination of scientific methods and technological processes revolutionizes the planning and realization of pharmaceutical filling equipment.
Optima Pharma provides the flexibility needed with the OPTIMA MultiUse platform. The MultiUse machines are proficient in processing different primary packaging materials – vials, syringes, cartridges, including ready to use components – and only have a minimum space requirement, since the basic machine does not have to be exchanged. Users will also save time due to the adjustable transport system that does not require any format parts. A variety of technologies minimizes product loss. Re-dosing upon request, short hose lines, 100%-In-Process-Control for vials, syringes and cartridges, weigh-dosing, re-capping upon request and much more.
CP: Are there any specific challenges clients are looking to overcome?
JD: Our customers are increasingly wishing for their machine solutions to cover a wide range of requirements: large and small batch sizes, ready to use syringes and bulk products, expensive and low-priced products, all possible container types such as syringes, vials, cartridges and special devices. All this requires a high degree of flexibility and solution orientation.
CP: What are some of the latest advances in manufacturing equipment?
JD: Here, for example, the filling of ready to use components should be mentioned. Ready to use components are suitable for the efficient filling of small, rapidly changing batches. They offer the necessary degree of flexibility. Flexible filling solutions such as the OPTIMA MultiUse Fillers are most in demand, which can be used to fill syringes, vials and cartridges of different sizes on a single machine.