Lipipor™ TNA2E Filter for Parenteral Nutrition (EU) product photo Primary L

Lipipor™ TNA2E Filter for Parenteral Nutrition (EU)

Patient Protection

  • Air: preventing embolism by position - independent air elimination
  • Particles: protecting the circulatory system against the undesirable effects of particulate contamination in peripheral and central venous infusions
  • Enlarged lipid droplets: significantly reducing the number of enlarged droplets (>5 μm) in admixtures1
  • Microbes: reducing the risk from inadvertently contaminated infusates, particularly with fungi of clinical importance

Benefits

  • Gravity prime and easy to use: the Pall Lipipor TNA2E filter minimizes nursing time and reduces set manipulation
  • Gravity flow: can be used in applications that do not need an infusion pump
  • Low protein binding: the Pall Lipipor TNA2E filter membrane has been demonstrated to have low protein binding 
  • Slim smooth housing design: is comfortable for patients and easy to tape in place
  • Membrane compatibility: the Pall Lipipor TNA2E filter membrane does not adversely affect normal lipid size distribution
The Pall Lipipor TNA2E Filter is a self-priming, air-eliminating filter with a 1.2 μm low protein binding Supor membrane and non-phthalate fluid pathway. It is indicated for the removal of inadvertent particulate debris, enlarged lipid droplets, fungal contaminants and entrained air that may be found in parenteral nutrition containing lipid.

Inadvertent contamination of parenteral nutrition preparations can have serious consequences

  • Air can become entrained in infusions due to degassing, disconnection or run-dry. It may not be visible in lipid-containing preparations. It can be particularly problematic on central venous line infusions, leading to air embolism2.
  • Particulate contamination arises from infusion systems, infusate components, manipulations3,4 and as precipitates due to interactions between components5. Particles are deposited in the microvasculature of the lungs and other organs and may have serious clinical consequences6. Gross precipitation in admixtures has proved fatal and may not be visible when lipid is present5.
  • Enlarged lipid droplets arise in admixtures due to instability. It has been suggested that the proportion of lipid present as droplets >5 μm should be minimized, since large numbers may lodge in the lung microvasculature and produce an embolic syndrome1.
  • Microbial contamination can arise in infusion systems inadvertently due to manipulations. Parenteral nutrition is an acknowledged risk for fungaemia with Candida species being the most common organisms involved7. Malassezia furfur is also emerging as an increasingly important pathogen in neonates8. These fungi are able to survive and grow in lipid-containing preparations 8,9.

References:

  1. Driscoll DF et al. JPEN 1996;20:296-301.
  2. Coppa GF et al. JPEN 1980;5:166-8.
  3. Foroni LA. J Parent Sci Technol 1993;47:311-4.
  4. Ball PA et al. Clin Nutr 1999;18(S1):14-5.
  5. US FDA Safety Alert. Am J Hosp Pharm 1994;51:1427-8.
  6. Walpot H et al. Anaesthetist 1989;38;544-8.
  7. Vazquez JA et al. J Infect Dis 1993;168:195-201.
  8. Robinson R & Ball P. Pres. NZ Hosp Pharm Assoc Meeting, October 1996.
  9. Validation Guide for Pall Lipipor Filters, 2002.
  10. Scheckelhoff DJ et al. Am J Hosp Pharm 1986;43:73-7.
  11. Stephens A. Poster pres. Ann Meeting BAPEN, November 2001



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Description

Patient Protection

  • Air: preventing embolism by position - independent air elimination
  • Particles: protecting the circulatory system against the undesirable effects of particulate contamination in peripheral and central venous infusions
  • Enlarged lipid droplets: significantly reducing the number of enlarged droplets (>5 μm) in admixtures1
  • Microbes: reducing the risk from inadvertently contaminated infusates, particularly with fungi of clinical importance

Benefits

  • Gravity prime and easy to use: the Pall Lipipor TNA2E filter minimizes nursing time and reduces set manipulation
  • Gravity flow: can be used in applications that do not need an infusion pump
  • Low protein binding: the Pall Lipipor TNA2E filter membrane has been demonstrated to have low protein binding 
  • Slim smooth housing design: is comfortable for patients and easy to tape in place
  • Membrane compatibility: the Pall Lipipor TNA2E filter membrane does not adversely affect normal lipid size distribution
The Pall Lipipor TNA2E Filter is a self-priming, air-eliminating filter with a 1.2 μm low protein binding Supor membrane and non-phthalate fluid pathway. It is indicated for the removal of inadvertent particulate debris, enlarged lipid droplets, fungal contaminants and entrained air that may be found in parenteral nutrition containing lipid.

Inadvertent contamination of parenteral nutrition preparations can have serious consequences

  • Air can become entrained in infusions due to degassing, disconnection or run-dry. It may not be visible in lipid-containing preparations. It can be particularly problematic on central venous line infusions, leading to air embolism2.
  • Particulate contamination arises from infusion systems, infusate components, manipulations3,4 and as precipitates due to interactions between components5. Particles are deposited in the microvasculature of the lungs and other organs and may have serious clinical consequences6. Gross precipitation in admixtures has proved fatal and may not be visible when lipid is present5.
  • Enlarged lipid droplets arise in admixtures due to instability. It has been suggested that the proportion of lipid present as droplets >5 μm should be minimized, since large numbers may lodge in the lung microvasculature and produce an embolic syndrome1.
  • Microbial contamination can arise in infusion systems inadvertently due to manipulations. Parenteral nutrition is an acknowledged risk for fungaemia with Candida species being the most common organisms involved7. Malassezia furfur is also emerging as an increasingly important pathogen in neonates8. These fungi are able to survive and grow in lipid-containing preparations 8,9.

References:

  1. Driscoll DF et al. JPEN 1996;20:296-301.
  2. Coppa GF et al. JPEN 1980;5:166-8.
  3. Foroni LA. J Parent Sci Technol 1993;47:311-4.
  4. Ball PA et al. Clin Nutr 1999;18(S1):14-5.
  5. US FDA Safety Alert. Am J Hosp Pharm 1994;51:1427-8.
  6. Walpot H et al. Anaesthetist 1989;38;544-8.
  7. Vazquez JA et al. J Infect Dis 1993;168:195-201.
  8. Robinson R & Ball P. Pres. NZ Hosp Pharm Assoc Meeting, October 1996.
  9. Validation Guide for Pall Lipipor Filters, 2002.
  10. Scheckelhoff DJ et al. Am J Hosp Pharm 1986;43:73-7.
  11. Stephens A. Poster pres. Ann Meeting BAPEN, November 2001

Specifications

Technical Specification

Filter Medium Low protein binding 1.2 µm polyethersulfone Supor® membrane
Retention of Candida albicans 100% removal of a total challenge of up to 104 for 24 h 9,11
Tubing Extensions Non-phthalate PVC, 3mm ID
Hold up Volume
(Filter housing + extension tubings)
12 mL (approximately)

Maximum Recommended Flow Rate
a. Pumped
b. Under gravity

 


500 mL/hr*
500 mL/hr*
Maximum Working Pressure 2 bar (30 psi)
Luer Lock Connectors
(in accordance with ISO 594-2: 1998)
Female inlet
Male Outlet
Sterilization Method Gamma irradiation
 Usage Single patient use. Change at 24 h. Where aseptically attached in an aseptic environment to a single infusion system and container of infusate that are intended for 2 days continuous pumped infusion, the filter may be used for up to 48 h.
* For a typical lipid containing admixture
Type
In-line Filters
Use
Filtration
Ordering Information
Description Reorder Number Packaging
 Pall Lipipor TNA Filter for Parenteral Nutrition  TNA2E  50 units per case
Application
Hospital Infusion, Hospital Infusion