SP Scientific Products (SP) has expanded its freeze dryer loader range with the launch of two new fully GMP compliant loading systems compatible with SP Hull LyoConstellationTM freeze dryers. Designed for advanced aseptic pharmaceutical processes involving lyophilization, SP’s 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 SP 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 SP 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 a unique loading system for full line vial applications requiring higher-speeds and capable of accommodating loading speeds up to 400 vials per minute.
SP’s new freeze dryer loading systems fully integrate with the SP Hull LyoConstellation range of development, pilot, and production freeze dryers. This freeze dryer range is designed for aseptic operation.
For operation under aseptic and low particle-controlled conditions, the new SP 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 sanitization.
Further optimizing GMP aspects for freeze dryer loading, human intervention is eliminated or minimized 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.