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Manufacturing

  • Our manufacturing workload may be divided into two types - sterile and non-sterile manufacturing.

    Sterile Manufacturing

    Different processes of manufacture are used:

    • in-process sterilisation - work in laminar flow cabinet and/or filtration
    • terminal sterilisation such as filtration and/or autoclaving.

    Three cross-flow laminar cabinets are used, and located inside a positive-pressure clean-room. Operators wear Clean Room gowns, gloves, boots and masks, and follow washing-up procedures before entering the clean room. Regular checks of various quality control (QC) procedures are undertaken including: Horse Blood Agar plates (HBA), Addicheks, Tween 80 plates, assays, pyrogen testing.

    Patient specific parenteral nutrition is a hallmark product of the sterile suite.

    The senior pharmacist in manufacturing attends the Nutrition Support Service ward rounds twice weekly to assist in coordinating and streamlining manufacture and planning nutritional goals and formulation adjustments.

    Prescribers are able to vary the volume of fluid, the amino acid content, the carbohydrate (glucose) concentration and the amounts of various electrolytes, based on 6 standard formulas.

    Vitamin additions vary according to the age and weight of patients. Other optional additives include selenium, carnitine, ascorbic acid and zinc. A solution of necessary trace elements is manufactured by the department and added to each nutrition formula. Biochemical parameters are monitored to reconcile electrolyte orders in the TPN solutions and ensure the formula is appropriate with respect to renal and liver function, blood glucose and serum triglyceride measurements. Infusion rates are calculated and monitored to ensure manufacture of an adequate supply whilst avoiding wastage.

    All solutions are prepared under aseptic conditions in laminar flow cabinets and undergo final filtration. A computer program, developed by the pharmacy department, allows the printing of worksheets to facilitate TPN preparation.

    Other sterile preparations include:

    • haemofiltration replacement solutions, plasmaphoresis solutions, lactate-free peritoneal dialysis solution,
    • some IV additives,
    • amethocaine/lignocaine/adrenaline solutions,
    • trace elements solution,
    • series dilutions of antigenic compounds for allergy testing,
    • copper histidine solutions,
    • sodium benzoate injection.

    Numerous other items are made and 'once-off' products may be prepared following research into stability and sterility issues.

    All bulk-manufactured products are kept in quarantine until all quality control results have been received and are satisfactory.

    Cytotoxic additives for inpatients and outpatients are made in downflow cabinets in the oncology pharmacy. Drugs to be administered via a central line for immunosuppressed haematology and oncology patients are made in the oncology pharmacy.

    Non-Sterile Manufacturing

    Pharmaceutical requirements in a paediatric hospital are unique as smaller doses are required and the difficulties in administering those doses make it necessary to produce a large number of non-standard formulations. The department compounds a wide range of products for oral, topical or rectal use. Many standard products use official formulas, but for others 'non-standard' formulas exist. These may be products that have been effectively used in other institutions, quoted in journals or supplied by drug companies.

    The department manufactures many oral liquid preparations (i.e. mixtures) of commonly used drugs. When products are insoluble or unstable in mixture form, powders may need to be made. Individual powder preparation requires considerable time and effort. In other cases, doses can be packed into empty gelatin capsules.Often tablets or capsules need to be crushed to be incorporated into a compound preparation. Other products such as paracetamol and diazepam are formulated into suppositories or enemas to facilitate administration.

    Examples of Non-sterile products manufactured at RCH:

    • 4-Amino salicylic acid enemas
    • Azathioprine suspension, 5 mg/mL
    • Biotin mixture, 10 mg/mL
    • Calciferol mixture 2,000 units/mL & 100,000 units/mL
    • Diazepam rectal solution RCH, 1 mg/mL
    • D.M.S.O. ointment 15%
    • Glycopyrrolate suspension, 0.5 mg/mL
    • Isoleucine (L-Isoleucine) solution 1%
    • Lemon spirit
    • Lemon syrup
    • Methylcellulose 2% base
    • Omeprazole dispersion, 2 mg/mL
    • Phenobarbitone sodium syrup, 3 mg/mL
    • Polycitrate mixture
    • Powders of specific drugs
    • Salicylic acid 1% and sulphur 1% ointment
    • Shol's solution
    • Sildenafil suspension, 2 mg/mL
    • Sotalol mixture, 5 mg/mL
    • Tacrolimus suspension, 1 mg/mL
    • Tragacanth spirit
    • Trimethoprim suspension, 10 mg/mL
    • Valine (L-Valine) solution 1%

    Please contact Drug Information on 03 9345 5208 for more information.

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