The medical and pharmacological industries utilize parenteral drug preparations to aid millions of individuals annually in achieving better health and improved quality of life. Parenteral drug preparations encompass solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, as well as gels for injection. Regardless of the form these preparations take, they are inherently sterile. Given their direct administration into patients’ bloodstreams, it is imperative that these preparations are meticulously protected to safeguard patients’ lives.
Enter the intravenous (IV) bag, a ubiquitous drug delivery format employed daily to deliver parenteral solutions for a myriad of patient healthcare services, ranging from hydration to cancer treatment. The market for PVC IV bags is expanding, as is the market for non-PVC IV bags.
- Non-PVC IV Bags Market: The global market size for non-PVC IV bags was valued at USD 1.8 billion in 2023 and is projected to grow to USD 4.4 billion by 2032, with a compound annual growth rate (CAGR) of 10.7% during the forecast period from 2024 to 20321.
- PVC IV Bags Market: The global market size for PVC IV bags was valued at USD 6.79 billion in 2023 and is expected to reach USD 9.5 billion by 2030, growing at a CAGR of 4.7% from 2024 to 20302.
In the event of an IV bag leak, contaminants such as microorganisms, reactive gases, and other substances could potentially breach the container closure barrier, adversely affecting the solutions within. Adherence to United States Pharmacopeia (USP) 1207 Container Closure Integrity Testing ensures proper inadequate testing to mitigate and prevent the potential sterile barrier loss in IV bag format. To ensure patient safety, documented protocol and report related to third-party primary packaging IV bag testing is essential to maintain sterility. CCIT employs non-destructive inspection methods to ascertain whether a drug container, such as an IV bag, is maintaining a sterile barrier against potential contaminants.
The USP establishes standards for the quality, purity, strength, and identity of pharmaceuticals. The organization publishes documentary standards and develops USP Reference Standards, which compounders/manufacturers use to test products and ensure compliance with published specifications. The reference standard for container closure integrity testing is USP 1207. USP 1207 mandates that CCIT on packages or containers, including pharmaceutical bags such as IV bags, be tailored to the specific container and the product inside. A formal testing method must also be developed and validated for the container. According to the standard, various technologies may be employed for CCIT, including high-voltage leak detection of plastic or glass, pressure and vacuum decay testing, gas leak testing, and headspace analysis.
When selecting the type of CCIT and developing a testing method, several questions should be considered in reference to the standard. What type of container is being tested: a vial, syringe, or IV bag, etc.? How is the container sealed or closed? How was the container compounded/manufactured, and what sterilization process will it undergo? What is the drug product inside the container? How full is the container, and is there headspace in it? How will the container be used, and what processes will it undergo? At what temperature(s) will the container be stored and shipped? Not all testing methods are suitable for all container types, contents, processes, or uses.
MediZap research and development team is building IV bag Packaging Solutions that are pre-validated to E-Beam | X-Ray Terminal Sterilization.
Footnotes:
1. Raksha Sharma, Growth Market Reports, 2023, Non-PVC IV Bags Market Size, Share, Growth & Forecast [2032], https://growthmarketreports.com/report/non-pvc-iv-bags-market-global-industry-analysis>
2. Geographic Scope And Forecast, Verified Market Reports, June 2023, Global PVC IV Bag Market By Type (100ML, 250ML), By Application (Nutrient Solution Delivery, Drug Delivery), https://www.verifiedmarketreports.com/product/pvc-iv-bag-market/