Saline Bags

Saline Bags Manufacturing

Saline IV bags are critical supplies needed for your healthcare system’s medical facilities and medical emergency transport vehicles. Isikel is poised to open a new saline bag manufacturing facility here in the US and will have sterile saline bags for sale in a range of industry standard sizes. Isikel is excited to be your healthcare system’s source for consistently available, FDA approved, saline solution bags. With the essential medical supplies you need on hand, your clinicians can provide optimal patient care while avoiding work-arounds that consume valuable resources and impact healthcare costs and budgeting.

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Manufacturing Timeline

About The Saline Bags

Saline bags for IV treatment, also known as IV bags, contain a solution of sodium chloride (salt) and sterile water that is compatible with your body’s tissues and fluids. The bag is a flexible container, made of soft plastic or vinyl, that has two ports: an injection port where medicine or fluids other than those in the saline solution can be added and the spike port that connects the IV tubing to the patient’s catheter.

Isikel Saline IV Bags

We will be manufacturing a range of two-port saline bags to meet the needs of any healthcare system: 50mL (a partial fill of the 100mL bag), 100mL, 250mL, 500mL, and 1000mL. Our bags are made from non-leaching polypropylene that will NOT contain PVC or DEHP. The nonpyrogenic solution is sterilized by a water cascade terminal sterilizer in-house, eliminating the need for third party sterilization services. Our saline bags have the capability to easily expand to D5W (Dextrose 5% Water) and LR (Lactated Ringers).
  • 2-port [IV bag spike & injection port] bag
  • Polypropylene [PP] bags for non-leaching properties
    • Will NOT contain PVC or DEHP
  • Sizes to manufacture
    • 50mL [partial fill 100mL bag]
    • 100mL
    • 250mL
    • 500mL
    • 1,000mL
  • FDA ANDA [Abbreviated New Drug Application] with expedited Pre-ANDA submission to improve timeline by 60 days
  • Sterilized by water cascade terminal sterilizer in house; eliminating the need for 3rd party sterilization services
  • Capability to expand to D5W [Dextrose 5% Water] and LR [Lactated Ringers]

What Are Saline Bags Used For?

The water in the saline solution helps to hydrate your body while the sodium chloride replenishes essential electrolytes. Saline IV treatment can sustain patients during surgery or be used to facilitate drug delivery in a direct and fast-acting manner when added to the saline bag. Saline bags are a first line of treatment for dehydration and are crucial for treating emergency patients or those receiving ICU medical care.

How Are Saline Bags Used?

The saline IV bag is hung on an elevated stand or pole and connected via tubing to a catheter that is attached into an intravenous needle that is typically placed in the patient’s hand or arm. The saline solution then flows into the patient’s bloodstream via gravity or with the use of a pump.

Saline Bag Supply Chain Solution From Isikel

Saline bag supply shortages have been an ongoing struggle in the US for several years. Supply was unable to keep up with demand as early as 2008 and was then compounded by years of manufacturing delays, heavy damage to a key saline bag manufacturing facility during Hurricane Maria, a severe flu season in 2014, and the COVID-19 pandemic which also brought extreme demand followed by additional supply chain delays. 

 

While importation of saline IV solutions from other countries can provide some small measures of assistance, it is not a long-term solution. Countries around the world are experiencing the same supply shortages as the US, and they cannot continuously supply other countries without risking additional shortages in their own medical systems. Saline bags are also difficult and costly to ship these long distances due to their bulk and weight.

 

The best way to resolve this supply chain issue for our US healthcare systems and facilities is to manufacture and produce more saline bags domestically. Soon, Isikel will be able to contribute to this effort and supply IV solutions needed for hospitals, home health care services, and beyond.