Pathogen Safety

The pathogen safety for cell lines used in the production of rAHF-PFM is discussed below. 

Specific virus reduction values achieved with each individual viral removal/inactiva-tion step are cumulative, so that the final viral reduction value attained reflects multiple removal and/or inactivation procedures occurring throughout the process. In summary, the processing of rAHF-PFM is associated with a significant viral reduction capacity for both lipid-enveloped and non-lipid-enveloped viruses and provides additional assurances of reliability with respect to pathogen safety. 

The formulation of rAHF-PFM without any human- or animal-derived additives provides further significant benefit to its overall pathogen safety profile. A sugar-based formulation of trehalose and mannitol is used to replace human serum albumin to stabilize the final formulation (see Section 3.3.3). 

Groner A (2008) Pathogen safety of plasma-derived products -Haemate P/Humate-P. Haemophilia 14(Suppl 5) 54—71... 

Centers for Disease Control and Prevention. Smveillance for Acute Hepatitis - United States, 2007, Morbidity and Mortality Weekly Report (MMWR), Vol. 58, Surveillance Summaries (SS-3), May 22, 2009 http //www.cdc.gov/mmwr/PDF/ss/ss5803.pdf, (accessed Aug 2015). Public Health Agency of Canada. Pathogen Safety Data Sheets and Risk Assessment http //www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php, (accessed Aug 2015). 

At 70—140°C, peroxide is vaporised. Peroxide vapor has been reported to rapidly inactivate pathogenic bacteria, yeast, and bacterial spores in very low concentrations (133). Experiments using peroxide vapor for space decontamination of rooms and biologic safety cabinets hold promise (134). The use of peroxide vapor and a plasma generated by radio frequency energy releasing free radicals, ions, excited atoms, and excited molecules in a sterilising chamber has been patented (135). 

Hygiene and Regulation Almost unique to MF is the influence of regulatoiy concerns in selec tion and implementation of a suitable microfilter. Since MF is heavily involved with industries regulated by the Food and Drug Administration, concerns about process stabihty, consistency of manufacture, virus reduc tion, pathogen control, and material safety loom far larger than is usually found in other membrane separations. 

HS(Rjl2 A guide to the Health and Safety (Dangerous Pathogens) Regulations 1981... 

OSHA s HAZWOPER standard eontains speeifie requirements with regard to medieal surveillanee of emergeney response team members and provision by the physieian of a written medieal report to the individual. As eited in the OSHA instruetion, if response aetivities involve infeetious materials, the site is to eomply with 29 CER 1910.120 (q) and may also have to eomply with 29 CER 1910.1030, Bloodborne Pathogens. If there is a eonfliet or overlap, the provision that is more proteetive of employee health and safety applies. 

There is much concern for the safety of personnel handling articles contaminated with pathogenic viruses such as hepatitis B virus (HB V) and human immunodeficiency vims (HIV) which causes acquired immune deficiency syndrome (AIDS). Some agents have been recommended for disinfection of HBV and HIV depending on the circumstances and level of contamination these are hsted in Table 10.4. Disinfectants must be able to treat rapidly and reliably accidental spills of blood, body fluids or secretions from HIV infected patients. Such spills may contain levels of HIV as high as lO" infectious units/ml. Recent evidence Irom the Medical Devices Agency evaluation of disinfectants against HIV indicated that few chemicals could destroy the vims in a... 

Pathogen Recommended and Alternative Antimicrobial Therapy (Adult Doses Pediatric Doses) Adverse Effects/Safety Monitoring Duration (Days)... 

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