B. Braun
B Braun Sterile Water for Injection Mini Plasco 10 ml or 20 ml Box of 20
B Braun Sterile Water for Injection Mini Plasco 10 ml or 20 ml Box of 20
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Product Overview
B. Braun Mini Plasco Sterile Water for Injection is a single-dose, hypotonic, preservative-free water for injection (WFI) compliant with the European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) monographs for water for injection. Its primary clinical role is as a vehicle for the reconstitution of lyophilised parenteral drugs whose Summary of Product Characteristics (SmPC) specifies water for injection as the validated diluent — commonly cephalosporins (ceftriaxone, cefepime), glycopeptides (vancomycin, teicoplanin), corticosteroids (hydrocortisone sodium succinate), and select hormones (oxytocin, octreotide).
The Mini Plasco container is a polyethylene plastic ampoule with twist-off opening, eliminating glass particulate risk, and supports needle-free aseptic transfer when paired with B. Braun Mini-Spike, NRFit, or Luer-access dispensing devices. The container is PVC-free, latex-free, and DEHP-free. Sterile water is hypotonic (0 mOsm/L) — critical that clinicians confirm the reconstituted final solution is iso-osmotic before parenteral administration; pure WFI must never be administered intravenously without dilution due to the risk of haemolysis and electrolyte disturbance.
Specifications
| Manufacturer | B. Braun Melsungen AG, Germany |
| Composition | Water for Injection (Aqua ad iniectabilia) Ph. Eur. / USP |
| Tonicity | Hypotonic, 0 mOsm/L — not for direct IV use |
| pH | 5.0–7.0 |
| Volume | 10 mL or 20 mL polyethylene Mini Plasco ampoule |
| Container | Single-dose, twist-off polyethylene; PVC-free, latex-free, DEHP-free |
| Sterility | Sterile, non-pyrogenic, preservative-free, antimicrobial-free |
| Pharmacopoeia | Ph. Eur. monograph 0169 Water for Injections; USP monograph Water for Injection |
| Endotoxin Limit | <0.25 EU/mL per Ph. Eur. monograph |
| Packaging | Box of 20 ampoules |
| Regulatory | HSA Singapore registered; CE Mark MDR 2017/745; ISO 13485:2016 quality management; ISO 15378 primary packaging materials for medicinal products |
| Storage | Store below 25°C; do not freeze; protect from light; single-use — discard residual |
Clinical Indications
- Reconstitution of lyophilised IV antibiotics (ceftriaxone, cefepime, vancomycin, teicoplanin) per the manufacturer SmPC
- Reconstitution of lyophilised corticosteroids (hydrocortisone sodium succinate, methylprednisolone) for IV bolus or infusion
- Reconstitution of select hormones and biologicals (oxytocin, octreotide, growth hormone) where WFI is the validated diluent
- Diluent for nebulizer therapy where the prescribed medication SmPC specifies water for injection
- Reconstitution of intramuscular injections and depot preparations per product-specific SmPC
- Pharmacy-compounded sterile preparations (CSPs) per USP <797> standards where WFI is required
Frequently Asked Questions
Q: Why can’t Sterile Water for Injection be administered intravenously on its own?
A: WFI is hypotonic (0 mOsm/L). Direct intravenous infusion of pure WFI causes acute intravascular haemolysis, haemoglobinuria, and electrolyte disturbance. WFI must be combined with the prescribed lyophilised drug to produce a final iso-osmotic or near-iso-osmotic solution before administration, in line with the drug’s SmPC reconstitution instructions.
Q: What is the difference between Sterile Water for Injection and Bacteriostatic Water for Injection?
A: Sterile WFI is preservative-free and intended for single-dose use. Bacteriostatic Water for Injection contains 0.9% benzyl alcohol as a preservative and supports multi-dose use. Benzyl alcohol is contraindicated in neonates (gasping syndrome) and certain paediatric populations — always use preservative-free Sterile WFI in those groups per FDA and AAP guidance.
Q: Can the ampoule be used to reconstitute multiple vials?
A: No. Mini Plasco is a single-dose container. ASHP, USP <797>, and Singapore healthcare infection control standards require any residual to be discarded immediately after first puncture or opening. Multi-vial reconstitution from a single ampoule is a recognised compounding error and source of microbial contamination.
Q: Is the product HSA Singapore registered?
A: Yes. B. Braun Sterile Water for Injection Mini Plasco is HSA-registered for use in Singapore healthcare facilities. It also carries CE Mark under EU MDR 2017/745 and is manufactured to ISO 13485:2016 quality management with ISO 15378 primary packaging compliance.
Q: How does Mini Plasco compare with glass ampoules of WFI?
A: Mini Plasco polyethylene eliminates glass particulate (a recognised contaminant of glass ampoule fracture per ISMP advisories), reduces sharps injury risk during opening, and supports needle-free aseptic transfer using B. Braun spike or transfer devices. The pharmaceutical content of WFI is identical and meets the same Ph. Eur. and USP specifications.
References: Ph. Eur. monograph 0169 Water for Injections; USP monograph Water for Injection; USP <797> Pharmaceutical Compounding Sterile Preparations; FDA guidance on benzyl alcohol in neonates; ISMP guidance on glass particulate; HSA Singapore therapeutic product framework; CE MDR 2017/745; ISO 13485:2016; ISO 15378.
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