Procedures:

• A risk assessment for the different types of feed should be done. There are types of feed with elevated hygiene risks like tube feeding and unfreezing and supplementing extracted human milk. The procedures for preparation must be specified in detail. A picture board is recommended to illustrate the different preparation procedures for the staff. The preparation of especially critical feeds can be done under a laminar airflow. Tools for risk management like a HACCP (Hazard Analysis Critical Control Point) concept should be applied and a detailed documentation of the preparation process must be established. This should include the key facts of the prepared formula such as batch number of formula, preparation staff, preparation time, preparation amount and storage temperatures. A retention sample of each prepared batch has to be kept for at least 5 days, preferably deep frozen.

Cleaning and disinfections:


Requirements for personnel:

• The personal hygiene of the employed staff has to be defined according to hand washing and disinfection. The hand washing and disinfection should be monitored by microbiological hand swabs on regular basis. Jewellery, skin piercings artificial fingernails and nail polish are not accepted. Behaviour rules for the milk preparation room have to be defined e.g. the use of cell phones is not allowed and

people with gastric or respiratory infections are not allowed in the room. The work clothing has to be worn exclusively in the milk preparation room. Hair and beards have to be covered and for critical operations, a mouth mask and possibly disposable gloves should be worn.

Quality controls (microbiological monitoring):

• The prepared formula, extracted human milk and the used materials like powders and equipment should be monitored on a regular basis. Details on the quality parameters of infant formula have been described before.

#### **6. Conclusions**

The personnel employed in the milk preparation room must have the appropriate qualifications to ensure compliance with these special hygienic requirements. The in-house monitoring systems and hygiene management measures have to be the subject of regular instructions and training. Personal hygiene, like regular, hygienic hand washing, and wearing of hygienic clothing, including a head covering and possibly disposable gloves, is the personal responsibility of each employee. The hygienic approach to infant formula preparation and compliance with all guidelines, together with the full documentation and reporting of deviations from these rules is a management task for the concerned section.

In the case of premature babies and immunocompromised infants, the assessment of the individual nutritional requirements is the responsibility of the medical practitioner. This includes also the risk assessment for lactogenic viruses. There are some viruses, which can be transferred from the lactating mother to the newborn with human milk. The risks of infection have to be assessed individually regarding the clinical situation of the mother and the newborn [71].

In cases where breastmilk is not available sterile ready-to-feed formula products are the best alternative from a hygienic point of view. However, often these formulae do not meet the individual nutritional needs of an especially susceptible group of infants to the fullest extent. Accordingly, these products or the breastmilk must often be enriched with food supplements like breastmilk fortifiers. Their addition poses a hygiene risk and has to be done as hygienically as possible immediately before use as described above.

Powdered infant formula provides some more flexibility to combine the feed according to the individual requirements of the infant. However, the powders are not sterile. The reconstitution of the formula with water at temperatures above 70°C has often been recommended to reduce the microbiological risk. But the procedure has been found to be very inefficient for this purpose. Therefore, a case-by-case decision should be made weighing the potentially damaging effects of heat on the individually formulated nutrient concentrate against the benefits of reducing microbiological risks. *Hygiene Aspects of Premature Nutrition DOI: http://dx.doi.org/10.5772/intechopen.107861*
