PALA™ YourTears™ 12 Core Kit
PALA YourTears 12 Core Kit features a closed-system header bag and integral 0.22-micron sterilizing-grade filter with a proprietary holding tray and twelve 5 mL eye drop bottles. The PALA YourTears 12 Core Kit provides up to 60 mL of serum tears. This kit enables clinicians to prepare serum tears without a clean room or laminar flow hood.
YourTears 12 Core Kit 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.
Core Kits do not include the mixing kit components nor the blood draw or saline solutions.
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 YourTears 12 Core Kit 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 without 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 YourTears 12 Core Kit is made using off-the-shelf proved components and meets all FDA requirements.
PALA YourTears 12 Core Kit meets or exceeds USP Chapter 797 standards, thereby achieving the "non-inferior" guidance.