Advantages of Mediflow

Mediflow’s IV infusions in PP bottles

Mediflow’s I.V bottles are manufactured using Polypropylene (PP) 1. An FDA approved medical grade and meets all the requirements of international safety standard for medical devices including US Class VI, EP method and U.S. FDA 21 CFR 177.1520 for I.R. and I.V. solution bottle with Autoclave sterilization (1).

PP is a flexible container and it does not stress crack in any condition (2). Thus ensuring against leaching during bulk handling and transportation, thus ensuring safe infusion therapy to patient.

Due to its stress crack free property, PP container is a good barrier against oxygen and other gasses (2). Thus protecting the infusion against permeation and ensuring excellent safety and guarantees drug purity in container.

PP is a hermetically closed container (3). Our technology allows us to produce self collapsible container thus allowing ensuring smooth flow of pure infusion with no need of air vent pricking during use. Thus it is a well closed container due its 3 stage protective layer of euro cap, which is designed to be airtight after re closure and during infusion therapy. IT is well documented that use of non-vented system for delivering IV fluids leads to decrease in the bacteriamias (4).

Mediflow’s I.V bottles high transparency gives it a crystal clear look. The end product in the bottle can be visualized with the naked eye for clarity giving optimal confidence in the purity of the product to the end-user of the I.V bottles.

All of Mediflow’s I.V infusion range is compatible with all ranges of Euro-Cap. This feature prevents the risk of considerable contamination and ease of addition of other medicines. Moreover it prevents from leakage from neck of bottle during syringe insertion and needle stick injury since it is made up of soft material (5).

PP has a high melting point and is in compliance with USP( United states Pharmacopeia) (6) and BP (British Pharmacopeia) (7), which prefers terminal sterilization of end product hermetically bottle at 121 centigrade at 15 min. thus assuring safe IV infusion container.

 

Conventional I.V infusion LDPE bottles

Conventional I.V bottles are manufactured using Low density poly-ethylene (LDPE). Which is world being over widely replaced by Polypropylene due its disadvantages as stated below.

LDPE is a stiff container and cracks under stress (2). Thus allowing possible leaching during bulk handling and transportation.

LDPE is relatively poor against oxygen and other gases (2), thus allowing permeation and moisture vapor transmission (2). As per FDA drug safety and Risk management Advisory committee, LDPE container are Permeable to volatile chemicals and gases thus concluding Ingress/Leaching of chemical contaminants into drug product formulations from packaging components demonstrates that permeation through LDPE is a real phenomenon (8).

LDPE bottles are mostly not self collapsible, which leads to the common practice of piercing the I.V bottles to facilitate the flow of the I.V solution. This allows air mixing with IV fluids, bottles which require air vent are more likely to be contaminated due to air mixing with IV fluids (4).

LDPE bottles are opaque. Lack of clarity makes it a compromised pharmaceutical container product.

LVP with nipple head are of hard plastic due to which in some case becomes difficult to insert spike and may result in needle stick injury and also administrating medication (5). Nipple top containers also don’t remain hermetically sealed after spike insertion.

LDPE bottle does not have high melting point so it requires more sterilization time at min 106 centigrade. Thus making extensive stability studies of assuring safe IV infusion container.

 

 

 


Bibliography
  1. SCG. SCG Chemicals. [Online] SCG. [Cited: march 5, 2014.] meets all the requirements of international safety standard for medical devices including US Class VI, EP method and U.S. FDA 21 CFR 177.1520 for I.R. and I.V. solution bottle with Autoclave sterilization.
  2. Pharmaceautical Packaging: Current Trend and Future. Khunteta, Vikas Pareek and Dr Alok. 2014, International Journal of Pharmacy and Pharmaceautical Sciences (vol 6), Vol. 6, p. 1.
  3. WHO. WHO guidlines. GENEVA : World Health Organisation, 2002.
  4. AIR MIXING with IV fluids and Injections. LODHA, RAKESH. New delhi : Indian Pediatrics, 2010, Vol. 47.
  5. Integrated Medical Industries (IMI). IMI. [Online] IMI, 2010. http://www.imi.com.ng/assets/downloads/productdetails.pdf.
  6. convention, UNITED states Pharmacopeial. The united states pharmacopeia. s.l. : The united states pharmacopeia, 2014.
  7. Health, Great Britian Department of. Methods of Sterilisation. BRITISH PHARMACOPEIA. london : Great Britian Department of Health, 2015, Vol. 5.
  8. Vibhakar Shah, Ph.D. Inhalation Drug Products in LDPE Containers: A quality (CMC) Perspective. FDA. [Online] may 05, 2004. [Cited: may 10, 2010.] www.fda.gov/ohrms/dockets/ac/04/.../2004-4040S1_02_FDA-Shah.pp.

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