THE ORIGINAL PALA KIT
The term "PALA" stands for Portable Aseptic Level Assurance. The patented PALA™ Convenience (PALA) Kit by AseptiKits™ LLC, comprises two kits. The PALA Dose preparation (PREP) kit and the Sterilizing and Filling Transport (Sterile) Kit.
The PALA™ Kit features a closed system bag and integral .2-micron syringe filter with a proprietary holding tray and four Nemera eye drop bottles. The PALA™ Kit provides a total of 40ml of serum eye drops. The PALA Kit enables clinicians to transfer solutions through the sterilizing grade filter into the sterile bag and the eye drop bottles. Use of PALA is simple and easy to use, requiring far fewer user steps compared to preparation under a laminar flow hood.
The PALA™ 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.
PALA PREP Kit
The first kit (“PALA Mixing Kit”) includes a set of mixing supplies for drawing and measuring the serum and saline and then mixing them to form a homogenous solution. The mixing supplies include (see FIGURE 1):
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Fenestrated drape
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Nitrile gloves
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60 mL luer lock syringe
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60 mL syringe with pre-attached female-female luer adapter
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Blood transfer barrel with female luer lock
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Four each 10 mL normal saline (0.9% NaCl) prefilled syringes
PALA Sterile Kit
The second kit is included in an insulated pouch and comprises a sterilized PALA closed system processing bag with integral .2-micron syringe filter. Inside the sterile PALA processing bag are:
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Four Nemera® eye drop bottles
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Four Nemera® eye drop bottle caps
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A proprietary eye drop bottle holding tray
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Attached and adhesed nozzle attached distally to the .2-micron filter
Biohazard
A biohazard label is also included. This allows users to return any potentially contaminated components to the zipper bag and apply the biohazard label to properly label and dispose of the biological materials.
The proprietary tray helps secure each eye drop bottle in an upright position to assist in avoiding spillage. This tray also holds the bottles such that each will not turn while threading the caps onto the bottles. 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™ 4 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™ 4 Kit.