THE NEW PALA 12 KIT
The PALA™ 12 Kit features a closed system bag and integral .2-micron syringe filter with a proprietary holding tray and twelve 5mL eye drop bottles. The PALA™ 12 Kit provides a total of 60ml of serum eye drops. The PALA 12 Kit enables clinicians to transfer solutions through the sterilizing grade filter into the sterile bag and the eye drop bottles. Use of PALA 12 is simple and easy to use, requiring far fewer user steps compared to preparation under a laminar flow hood.
The PALA™ 12 Convenience Kit can be used anywhere and under any environmental conditions to produce autologous blood serum eye drops for treating severe dry eyes. Processing can be done on site and without the need for a laminar flow hood. Common areas of intended use include doctor offices, lab sites and pharmacies.
The proprietary tray helps secure each eye drop bottle in an upright position to assist in avoiding spillage. All filling and capping of each eye drop bottle is completed from the exterior of the bag thereby maintaining product sterility throughout each procedure.
The kit is designed to enable clinicians to process and provide autologous blood serum eye drops in a normal saline (0.9% NaCl) solution of various prescribed concentrations on-site. The .2-micron syringe filter produces sterile eye drops in virtually any environment outside of a laminar flow hood.
Given the need to refrigerate the eye drops after processing, a set of freezer packs are also provided. These should be frozen in advance of processing each kit. After filling and closing the eye drop bottles a freezer pack is placed in the insulated pouch with the closed eye drop bottles and is then sealed for transport.
The kit was created using off-the-shelf proved components and meets all requirements pertaining to a “convenience kit” under FDA guidelines. The product is assembled by a contract manufacturer under an existing FDA 510(k) for procedure kits.
The PALA™ 12 kit enables clinicians to provide autologous serum eye drops in any environment where there is access to a phlebotomist, blood drawing supplies and a centrifuge. The mixing, filling and capping may be accomplished in a physician office (e.g.) using the PALA™ 12 Kit.