PALA 12 KIT
TM
PALA™ 12 features a closed-system header bag and integral 0.22-micron filter with a proprietary holding tray and twelve 5 mL eye drop bottles. The PALA 12 provides up to 60 mL of serum tears. The PALA 12 enables clinicians to prepare serum tears outside of clean room or laminar flow hood.
PALA 12 can be used onsite to produce autologous blood serum eye drops for treating severe dry eyes. Common areas of intended use include doctor offices, lab sites, patient homes, and pharmacies.
The proprietary tray secures each eye drop bottle in an upright position to assist in filling. Filling and capping of each eye drop bottle is accomplished from the exterior of the bag thereby maintaining product sterility throughout each procedure.
PALA 12 is designed to enable clinicians to process autologous blood serum tears in a normal saline solution in prescribed concentrations on-site. The 0.22-micron filter produces sterile serum tears in virtually any environment outside of a laminar flow hood.
Given the need to refrigerate the serum tears after processing, a freezer pack is provided for each kit. These should be frozen in advance of processing. After processing the serum tears the freezer pack is placed in the insulated pouch with the eye drop bottles for transport.
PALA 12 was created using off-the-shelf proved components and meets all FDA requirements.
PALA 12 meets or exceeds USP Chapter 797 standards, thereby achieving the "non-inferior" guidance.
