SP Scientific Products (SP) has expanded its freeze dryer loader range with the launch of two new fully GMP-compliant loading systems compatible with Hull LyoConstellation freeze dryers. Designed for advanced aseptic pharmaceutical processes involving lyophilisation, the latest loader introductions offer flexible and innovative solutions for small to medium batch and high-speed full line aseptic vial handling applications.
The two latest Hull Loaders are a Semi-Automatic Loader (SALS-30) and a high-speed Row-by-Row Loader (RxR-36) for fill-finish processing applications that include freeze dryers. The new compact Hull SALS-30 is designed to replace manual loading for medium and smaller batch applications (loading speeds up to 70 vials/minute). In addition, the SP Hull RxR-36 is an advanced loading system for full line vial applications requiring higher-speeds and capable of accommodating loading speeds up to 400 vials per minute.
The new freeze dryer loading systems fully integrate with the Hull LyoConstellation range of development, pilot, and production freeze dryers. This powerful freeze dryer range is specifically designed for aseptic operation, so when integrated with the new loading systems and filling lines, this ensures the best manufacturing freeze-drying practices, to achieve faster product progression from development to commercialization.
For operation under aseptic and low particle-controlled conditions, the new Hull freeze dryer loaders are fully compliant with the latest cGMP standards, ensuring the bridge and transfer plates never move through the grey space, an area below the aseptic processing plane. In addition, the systems are designed for easy cleaning and complete surface exposure during the decontamination process to ensure effective sanitisation.
Further optimising GMP aspects for freeze dryer loading, human intervention is eliminated or minimised by the SALS-30 and RxR-36 loaders, as human contact is only possible through glove ports. Both high-speed and low-speed systems are designed for isolation to protect aseptic product from operators, as well as provide containment to protect operators from potent or harmful products.