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In total, SANBAO’s product range currently comprises 27 different products. Out of these, 14 are intravenous infusions, 9 are medical devices and 4 are small volume parenterals. All of our products have been duly registered by the Ghana Food and Drugs Authority (FDA).
Intravenous infusions are also known as large volume parenterals or IV Fluids. Sanbao manufactures 14 different IV fluids using high quality injection grade raw materials which are packaged in Polypropylene (Non-PVC) bags.
Our primary packaging material for infusions has been changed from PVC to Polycine® Polypropylene (APP114) for the following reasons.
(1) FDA Guidance for Industry, December 2012, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products (available at https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm330792.htm)
The hermetic sealing of PP infusion bags produces a closed Infusion system for 100% protection against microbial or particulate contamination. This protection is also ensured by its collapsible nature and the absence of air venting;
PP bags consist of multi-layered film (3 layers) for better physico-chemical stability of the infusion during its shelf life. The Outer layer protects it against high moisture/vapour transmission rate; the middle layer provides strength to container whilst the inner layer provides stability against pH variation;
PP is non-carcinogenic and environmentally friendly.
Our new infusion package has medication and administration ports which are self-sealing and provides for drug mixing without air contamination.
Unlike PVC bottled infusions which must be vented before use, the ready-to-use, pre-sterilized outer surface of our PP bags saves critical time during emergencies.
PP bags can be sterilized at 121 °C for 15 minutes as per international standards, killing most heat resistant spore-forming bacteria without any significant effect on its integrity;
PP poses no serious health hazard as it is free from di(2-ethylhexyl) phthalate (DEHP), a plasticizer released from PVC into solution. Phthalates have been studied extensively in animals, and according to the USFDA, exposure to DEHP have been shown to be toxic to the male reproductive system of rats. In other studies, oral exposure to approximately 100-200 mg/kg/day of DEHP during gestation in female rats resulted in skeletal and cardiovascular malformations, neural tube defects, developmental delays, and intrauterine death of the offspring. While the data in humans are less clear, epidemiological studies suggest that certain phthalates may affect reproductive and developmental outcomes. (1)(FDA Guidance for Industry, December 2012). Hence, Sanbao has opted for PP as a better and safer alternative to PVC in ensuring optimal health and safety for all consumers.
PP bags have a relatively higher level of transparency enabling easy and effective visual inspection prior to administration.