Syntegon Services – at your side for the full lifecycle

Having the necessary expertise at hand for handling breakdowns swiftly is only half the battle. The other half is immediate access to the right spare parts when they are needed. Being prepared and able to react flexibly does not require keeping every component in stock. Instead, Syntegon’s Recommended Parts Inventory identifies the most critical parts for each machine configuration, enabling manufacturers to prioritize their inventory which can be ordered conveniently via the mySyntegon web shop.

Flexibility beyond maintenance is crucial for CDMOs. They must be able to meet changing demand in terms of capacity, products, and formats to remain competitive. Equipment should therefore not only handle a broad range of applications, but also support fast, efficient changeovers. Retrofits and modernizations can increase the flexibility of existing machinery, allowing manufacturers to adapt production without complete replacements. One example is the successful RABS retrofit on a liquid fill-finish line for Spanish CMO Inibsa: their modernized production helped to meet new customer requirements and resulted in winning a new customer thanks to the equipment’s full Annex 1 compliance.

Qualification and validation are major factors in a pharmaceutical product’s time-to-market and should therefore be efficiently planned and executed. Considering the complexities these steps entail, this can be a real challenge. Both equipment and processes must also comply with numerous regional and international regulations that are subject to change.

Syntegon Services support manufacturers throughout qualification and validation and help ensure compliant equipment and processes from development to commercial production. Experts well versed in international GMP requirements advise not only on production processes and technology, but also on storage, distribution, documentation, and data transparency. They also provide qualification and validation services tailored to specific production environments. The Syntegon Pharma Customer Centers around the world are the perfect testing ground to ensure compliant processes work as designed and are qualification- and validation-ready. Remote and on-site training helps operators implement them consistently and stay up to date on compliance requirements. Syntegon’s Pharma Customer Centers are also host to events like the OSD Academy that allows pharma professionals to advance their knowledge through hands-on training and expert exchange.

Manufacturers do not need to invest in entirely new equipment to comply with evolving regulations: retrofits and modernizations offer more than increased flexibility. Implementing, for example, digital monitoring systems, glove testing, or RABS as shown in Inibsa’s case, can bring existing production equipment in line with current regulations.