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Table 2 – No infectivity associated with feeding SDPP to susceptible pigs.


Virus PCR positive genome copies


Inclusion level


PCV-2 2.47×10 5.0 8% PCV-2 10 6.7


PCV-2 7.56×10 5.0 8% HEV Positive PEDV Positive PEDV Positive PRRSV Positive * NI = Not infective.


4%


8% 5%


3-8% 3-8%


Feeding duration 45 days 42 days 32 days 28 days 14 days


Results


NI* NI* NI* NI* NI*


7 to 14 days NI* 7 to 21 days NI*


Reference


Pujols and others (2008) Shen and others (2011) Pujols and others (2011) Pujols and others (2014) Campbell and others (2014) Crenshaw and others (2014) Crenshaw and others (2014)


During weaning and during vari- ous pathogen stress events, spray-dried por- cine plasma can help.


2. Testing of donation and plasma pools The second premise in the WHO guidelines is testing of dona- tions and plasma pools. The EAPA and NASDBPP producers daily and regularly conduct analyses of the collected raw ma- terial that guarantees or assures the microbiological or physi- cal-chemical quality of the finished product. Therefore, every single production lot is tested for microbial contamination to meet the strictest requirements for product quality as estab- lished by different worldwide regulations. In addition, PCR analysis to assure absence of cross species contamination or absence of specific pathogens are regularly conducted. Plas- ma pooling is also a recognised safety step in the production of certain human plasma products. Although neutralising antibodies of notifiable disease, like ASFv , will be absent, the pooling effect will dilute by 1,000 to 10,000 times the blood of any single animal. For endemic pathogens that induce neutralising antibodies like PCV2 , this step can reduce potential infectivity.


3. Viral inactivation and removal procedures According to WHO guidelines, the manufacturing process should incorporate steps validated to remove or inactivate a wide range of pathogens. These guidelines define a robust safety step as an effective and reliable process step able to re- move or inactivate substantial amounts of virus, typically four or more logarithms. Inactivation means that the virus is killed, or not capable of replicating. In addition, the WHO guidelines recommend that the production process should include one


robust processing step able to inactivate non-enveloped vi- ruses or two robust processing steps able to inactivate envel- oped viruses. One of the main safety steps in the manufactur- ing of SDPP agreed by the EAPA and NASDBPP producers is spray-drying at 80°


C throughout its substance. This step


aligns with the EU directive 2002/99/EC which recognises meat intended for human consumption – and that the heat treatment of 80°


activation step for many viruses. ‘Throughout its substance’ refers to achieving a designated temperature to the core of the mass. Spray-drying plasma to 80°


C throughout its sub-


stance simply means that each droplet of liquid plasma has achieved 80°


C and has effectively been heated to assure compliance for a safe product regarding.


OIE list pathogens Research has shown that spray-drying at 80°


C throughout its


substance inactivates several swine viruses of interest, includ- ing ASFv as shown in Table 1. Also, different peer reviewed publications reported that no infectivity was associated with feeding susceptible pigs diets for 7 to 45 days with high levels of commercial SDPP that was PCR+ to different tested viruses, see Table 2. Another safety step common for EAPA and NASDBPP members is post-dry- ing heat treatment of packaged product at ≥ 20°


C for 14 days.


The storage conditions for SDPP held at room temperature (~20°


C) for 14 days has been demonstrated to inactivate cer- tain pathogens like PEDv or PRRSv that are susceptible to dry


▶ ALL ABOUT FEED | Volume 27, No. 3, 2019 15 C throughout its substance is an effective in-


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