Donor screening

A variety of interlocking measures are taken to identify and qualify suitable donors. It should be noted that prospective milk donors are not offered any financial incentives.

1. Each potential donor must be recommended as a donor by their personal physician and infant's pediatrician. Amongst other reasons, this helps ensure that donors are not chronically ill and that the infant is in good health.


2. Each donor must complete an intensive screening questionnaire, which is reviewed by a qualified professional who documents the results in the donor tracking database. Unsatisfactory answers to certain key questions result in automatic deferral and questionable issues are referred to the medical director.


3. Each donor is screened for evidence of infection with several pathogenic viruses (HIV, Human T-Lymphotrophic Virus, Hepatitis A, B, and C, and Syphilis.) Any potential donor found positive on screening is permanently deferred.


4. Each donor is screened for drugs of abuse. Anyone testing positive is permanently deferred.


5. Each donor is required to undergo requalification every four months under the same protocol as used in their initial qualification. Any donor who does not requalify is deferred until such time as they do, or permanently deferred if necessary. (In the event of permanent deferral, all remaining milk provided by that donor is removed from inventory and destroyed.)


6. Each donor is given specially designed barcode-labeled containers and a breast pump. The donor pumps and freezes the milk until ready for shipment. Once received, the milk and container are examined for their condition and the barcode information checked against the database. If satisfactory, the units are placed in the milk center freezer until ready for further testing and processing.


7. Each donor's milk is sampled for DNA markers to guarantee that the milk is truly from the registered donor. This test is performed at a reference laboratory. Each milk specimen is stored frozen and quarantined until matching test results are received. If a donor's milk does not match the reference sample they are permanently deferred and all milk is removed from inventory and destroyed.
   
   Throughout the above process, any non-complying milk specimens are discarded. As is the case with blood donation centers, access to all confidential information about the donor, including blood test data, is tightly controlled.

Milk processing

No screening system can be 100 percent effective, and it is anticipated that an infected donor may occasionally get through the donor screening process. Therefore, the quality of the donor milk is further safeguarded by the manufacturing process.

1. The milk is briefly thawed and filtered through a stainless steel screen, to remove any solids.


2. It moves into an insulated process tank (P-1). The tank incorporates a continuous temperature monitoring system which chills the milk for the pooling process. The tank mixer is moves gently without spinning or foaming the milk which might damage important protein constituents.


3. The fat (cream) is then separated from the rest of the milk and the skim milk is transferred into a second process tank where it remains chilled. After the separation is completed the protein and fat content of the cream is determined and a portion of the cream is added back to the skim milk to achieve a specific protein and fat (calorie) content.


4. The resulting whole milk formulation is connected to the high-temperature, short-time (HTST) pasteurizer which raises the milk temperature in excess of 70º C (158 F) for a prescribed amount of time. This unique process ensures a safe product while maintaining desirable amounts of important proteins and vitamins.


5. After pasteurization, the milk flows into a second process tank (P-2) and is cooled. Following pasteurization, the milk product is processed aseptically (sterile).


6. After cooling, the pasteurized milk is pumped from process tank P-2 into a filling unit for dispensing into syringes. The final product is tested for viral and bacterial contamination prior to packaging and distribution.
   
   This process has been independently validated by the Netherlands Organization for Applied Scientific Research, Ziest, The Netherlands, in collaboration with Sanquin Research, Virus Safety Services, Amsterdam, The Netherlands.