Aseptic Dispensing

Total Parenteral Nutrition

• A method of feeding patients by infusing a mixture of all necessary
nutrients into the circulatory system thus by passing the GIT
• It is also known as artificial nutrition or parenteral alimentation
• Categories of TPN
– If enteral feeding is completely stopped or ineffective then total PN is used
– If the enteral feeding is not enough or sufficient then partial PN is used
• Indications of Parenteral Nutrition
• General: if a well nourished adult is starved for 7-10 days, then partial
PN is accepted, but when starvation exceed 10 days, then TPN is used
• Short Term: Bowel injury, Major trauma, burns, malabsorption,
malnutrition
• Long term: TPN’s indicated for long terms due to crohn’s syndrome,
Bowl resection
• Composition of TPN
– Macro components
• Carbohydrates
• Lipids
• Proteins
– Micro components
• Vitamins
• Electrolytes
• Trace elements
 TPN in Hospital Pharmacy
• TPN is a part of total care of any patient
• Therefore the preparation of TPN must be an integral
part of hospital pharmacy manufacturing program
irrespective of its size
• Its method of preparation are simple so does not
require any extensive budget or equipment
• Prepared in controlled environment like……
• Pharmacist should have knowledge of preparation
method, stability and compatibility, facilities,
equipment and environment required for TPN
preparation
• Stability and Compatibility
• As TPN is a mixture of complex pharmaceutical systems
(specially lipids), there is a chance of interaction or
incompatibilities between the ingredients, leading to impaired
therapeutic value or increase risk for its toxicity to the patients
• pharmacist must have knowledge about the incompatibilities
between ingredients, so can advise physicians accordingly,
and the available literature must be consulted prior to the
preparation
• Facility and environment
• As with other aseptic processes, environment can effect the
quality of TPN, so the facilities must thus be designed,
cleaned, maintained and monitored to the highest achievable
standards. For this purpose laminar flow hoods are used.
• Personnel and Training
– Personnel having suitable training should carry out aseptic preparation of
TPN.
– It covers aseptic techniques, and validation, and theoretical aspects like
patient’s requirements and use of products
• Documentation
– Complete documentation of the patient history, labels details, raw
material records, environmental record, preparation records all according
to GMP
• Manufacturing procedures/ guidelines
– Should be prepared by production and QC staff.
– All personnel should adhere to these guidelines.
• Preparation is initiated on receipt of the request for TPN. After
checking the feasibility and stability of the requested combination,
information can be then transferred to dispensing area
• Formulation and preparation
– Firstly identification and collection of required materials and then
assembling in aseptic condition
– Checked against the request sheet and prepared accordingly in
laminar air flow
– Care should be taken when more than one TPN’s are under process.
• Inspection
– The nutrition beg should be checked for leaks, splits, and
particulates.
• Labelling
Patient name ward product constituents
Batch (dispensing number) expiry date/time
Storage conditions
• Storage
• Packaging
• Dispensing
• Charging of TPN (according to the cost of
ingredients)