SP Scientific Products has expanded its freeze dryer loader range with two GMP-compliant loading systems compatible with the company’s LyoConstellation freeze dryers. Designed for advanced aseptic pharmaceutical processes involving lyophilisation, the latest loader introductions are suitable for both small to medium batch and high-speed full line aseptic vial handling applications.
The two latest systems are a semi-automatic loader (SALS-30) and a high-speed row-by-row loader (RxR-36) for fill-finish processing applications including freeze dryers. The SALS-30 is designed to replace manual loading for medium and smaller batch applications, with loading speeds up to 70 vials per minute. The RxR-36 is built for full line vial applications and is capable of loading speeds up to 400 vials per minute.
The loading systems also integrate with the company’s LyoConstellation range of development, pilot, and production freeze dryers. This freeze dryer range is designed for aseptic operation, so when integrated with the loading systems and filling lines, best manufacturing freeze-drying practices are ensured, SP says, helping users achieve faster product progression from development to commercialisation.
For operation under aseptic and low particle-controlled conditions, the freeze dryer loaders are fully compliant with 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.
Human intervention is eliminated or minimised by both models, 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.
