Identification of Sensitive Raw Materials at A Milk Preparation Room of A Neonatal Intensive Care Unit in the Canselor Tuanku Muhriz Hospital


  • Mahirah Mohamad Department of Food Sciences, Faculty of Science and Technology, Universiti Kebangsaan Malaysia, 43600 UKM Bangi Selangor, Malaysia
  • Shareena Ishak Department of Paediatric, Canselor Tuanku Muhriz Hospital, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia
  • Norrakiah Abdullah Sani Department of Food Sciences, Faculty of Science and Technology, Universiti Kebangsaan Malaysia, 43600 UKM Bangi Selangor, Malaysia


milk room, neonatal intensive care unit (NICU), sensitive raw materials


The implementation of a Hazard Analysis and Critical Control Point (HACCP) system in infant milk preparation can prevent and reduce the risk of bacterial contamination in infant feedings. Therefore, it is very important to determine the sensitive raw materials (SRM) in a milk room of a neonatal intensive care unit (NICU) to prevent contamination that can affect the safety of milk feeding. This study was conducted to identify the SRM at the milk preparation room of a NICU in the Canselor Tuanku Muhriz Hospital, Cheras, Kuala Lumpur, Malaysia. SRM were identified via HACCP system decision tree by the Malaysian Standard (MS1480:2007).. The results showed that donor expressed breast milk (DEBM), expressed breast milk at home (EBMH), freshly expressed breast milk (FEBM) and powdered infant formula (PIF) were identified as SRM. Expressed breast milk (DEBM, EBMH, FEBM) were known as non-sterile milk which were able to transmit pathogenic microorganisms such as Klebsiella pneumoniae and Pseudomonas aeruginosa derived from the mother or donor. PIF is also not sterile that are associated with Cronobacter sakazakii and Salmonella infections causing serious illnesses among premature and infants. Ready to feed milk (RTF) is classified as non-sensitive material as it is sterile, free from bacterial contamination and safe for high-risk infant’s feeding compare to PIF. Preventive measures were applied to control the significant hazards in all identified SRM to ensure the final product (milk) is safe for consumption.


Download data is not yet available.


Metrics Loading ...


ADA. 2011. Infant feedings: Guidelines for preparation of human milk and formula in health care facilities. 2nd Ed. Pediatric Nutrition Practice Group, United States of America.

Almeida, R.C.C., Matos, C.O. & Almeida, P.F. 1999. Implementation of a HACCP system for on-site hospital preparation of infant formula. Food Control, 10: 181-187. DOI:

American Academy of Pediatrics. 2012. Breastfeeding and the use of human milk. Pediatrics, 129(3): 827-841. DOI:

Amissah, E.A., Brown, J. & Harding, J.E. 2018a. Carbohydrate supplementation of human milk to promote growth in preterm infants. The Cochrane Database of Systematic Reviews, 8(8): CD000280. DOI:

Amissah, E.A., Brown, J. & Harding, J.E. 2018b. Protein supplementation of human milk for promoting growth in preterm infants. Cochrane Database of Systematic Reviews, 6(6): No. CD000433. DOI:

Angulo, F.J., Cahill, S.M., Wachsmuth, I.K., Costarrica, M.L. & Embarek, P.K.B. 2008. Powdered infant formula as a source of Salmonella infection in infants. Clinical Infectious Diseases, 46(2): 268-273. DOI:

Azevedo, I., Regalo, M., Mena, C., Almeida, G., Carneiro, L., Teixeira, P., Hogg, T. & Gibbs, P.A. 2005. Incidence of Listeria spp. in domestic refrigerators in Portugal. Food Control, 16: 121-124. DOI:

Bankhead, R., Boullata, J., Brantley, S., Corkins, M., Guenter, P., Krenitsky, J., Lyman, B., Metheny, N.A., Mueller, C., Robbins, S. & Wessel, J. 2009. A.S.P.E.N. Board of Directors. Enteral nutrition practice recommendations. Journal of Parenteral and Enteral Nutrition, 33(2): 122-167. DOI:

Baumer, J.H. 2004. Guidelines for the establishment and operation of human milk banks in the UK. Archives of Disease in Childhood, 89(1): 27–28. DOI:

Best, C. 2008. Enteral tube feeding and infection control: how safe is our practice? The British Journal of Nursing, 17(1036): 1038-1041. DOI:

Bicking, K.C., Koirala, S., Solomon, B., Rosenberg, J., Robinson, B.F., Neri, A., Laufer H.A., Arduino, M.J., Moulton-Meissner, H., Noble-Wang, J., Chea, N. & Gould, C.V. 2017. Pseudomonas aeruginosa outbreak in a neonatal intensive care unit attributed to hospital tap water. Infection Control and Hospital Epidemiology, 38(7): 801-808. DOI:

Boo, N.Y., Puah, C.H. & Lye, M.S. 2000. The role of expressed breastmilk and continuous positive airway pressure as predictors of survival in extremely low birthweight infants. Journal of Tropical Paediatric 46(1): 15-20. DOI:

Boo, N.Y., Nordiah, A.J. & Alfizah, H. 2001. Contamination of breast milk obtained by manual expression and breast pumps in mothers of very low birth weight. Journal of Hospital Infection, 49: 274–281. DOI:

Bowen, A.B. & Braden, C.R. 2006. Invasive Enterobacter sakazakii disease in infants. Emerging Infectious Disease, 12(8): 1185–1189. DOI:

Bowen, A., Wiesenfeld, H.C., Kloesz, J.L. 2017. Notes from the Field: Cronobacter sakazakii infection associated with feeding extrinsically contaminated expressed human milk to a premature infant — Pennsylvania. MMWR and Morbidity and Mortality Weekly Report 66(28): 761–762. DOI:

BDA. 2016. Guidelines for the Preparation and Handling of Expressed and Donor Breast Milk and Special Feeds for Infants and Children in Neonatal and Paediatric Health Care Settings. United Kingdom: British Dietetic Association.

Brown, N.M., Arbon, J. & Redpath, C.2000. Contamination of milk bank samples with Pseudomonas aeruginosa during pasteurisation by penetration of organisms through the screw lid during cooling. Journal of Hospital Infection, 46:321–322.CAC. 1997. Hazard Analysis and Critical Control Point (HACCP) system and guidelines. Codex Alimentarius Commission. DOI:

CAC. 2008. Code of hygienic practice for powdered formulae for infants and young children. CAC/RCP 66-2008. Codex Alimentarius Commission.

CDC. 1993. Centers for Disease Control and Prevention Salmonella serotype Tennessee in powdered milk products and infant formula - Canada and the United States, MMWR Morbidity and Mortality Weekly Report, 42: 516-517.

CDC. 2002a. How to prepare and store powdered infant formula during an emergency. (accessed 03.19.2023).

CDC. 2022b. Make water safe during an emergency. (accessed 08.18.2022).

Chan, G.M. 2003. Effects of powdered human milk fortifiers on the antibacterial actions of human milk. Journal of Perinatology, 23(8): 620-623. DOI:

Chenu, J.W. & Cox, J.M. 2009. Cronobacter (‘Enterobacter sakazakii’): current status and future prospects. Letters in Applied Microbiology, 49: 153–159. DOI:

Davidson, D.C., Poll, R.A. & Roberts, C. 1979. Bacteriological monitoring of unheated human milk. Archives of Disease in Childhood, 54(10): 760-764. DOI:

Donowitz, L.G., Marsik, F.J., Fisher, K.A. & Wenzel, R.P. 1981 Contaminated breast milk: A source of Klebsiella bacteremia in a newborn intensive care unit. Reviews of Infectious Diseases, 3(4): 716-720. DOI:

EPA.2021. Types of Drinking Water Contaminants.,as%20microbes%20or%20microbiological%20contaminants (accessed 08.18.2022).

FAO. 1998. Food Quality and Safety Systems – A Training Manual on Food Hygiene and the Hazard Analysis and Critical Control Point (HACCP) System. Rome: Food and Agriculture Organization.

FAO/WHO. 2006. Food and Agriculture Organization of the United Nations/World Health Organization, Enterobacter sakazakii and Salmonella in powdered infant formula; meeting report. Microbiological Risk Assessment Series, pp. 10

FAO/WHO. 2007. Safe Preparation, Storage and Handling of Powdered Infant Formula Guidelines 1–26. (accessed 12.07.2016).

FAO. 1997. Food and Agriculture Organization of the United Nations. HACCP Principles & Application Guidelines. (accessed 08.12.2022).

FAO/ WHO. 2008. Enterobacter sakazakii (Cronobacter spp.) in powdered follow-up formula. Meeting report. Rome, Italy. Food and Agriculture Organization.

Gad, S., Sheta, M.M., Al-Khalafawi, A.I., Abu El-Fadl, H.A., Anany, M., Sahmoud, S. & Amin, M.K. 2021. Expressed breast milk contamination in neonatal intensive care unit. Pediatric Health, Medicine and Therapeutics, 12: 307-313. DOI:

Gransden W, Webster, M., French, G.L. & Philips, I. 1986. An outbreak of Serratia marcescens transmitted by contaminated breast pumps in a special care baby unit. Journal of Hospital Infection, 7(2): 149-54. DOI:

Gras-Le Guen, C., Lepelletier, D., Debillon, T., Gournay, V., Espaze, E. & Roze, J. 2003. Contamination of a milk bank pasteurizer causing a Pseudomonas aeruginosa outbreak in a neonatal intensive care unit. Archives of Disease in Childhood-Fetal and Neonatal Edition, 88(5): 434-435. DOI:

Haiden, N., Pimpel, B., Assadian, O., Binder, C., Kreissl, A., Repa, A., Thanhäuser, M., Roberts, C.D. & Berger, A. Comparison of bacterial counts in expressed breast milk following standard or strict infection control regimens in neonatal intensive care units: Compliance of mothers does matter. Journal of Hospital Infection, 92(3): 226–228. DOI:

Hartmann, B., Pang, W., Keil, A., Hartmann, P. & Simmer, K. 2007. Best practice guidelines for the operation of a donor human milk bank in an Australian NICU. Early Human Development, 83(10): 667–673. DOI:

Himelright, L., Harris, E, Lorcg, V. & Anderson, M. 2002. Enterobacter sakazakii Infections associated with the use of powdered infant formula Tennessee. JAMA, 287(17): 2204–2205. DOI:

HMBANA. 2020. HMBANA Standards for Donor Human Milk Banking: An Overview. Fort Worth, Texas: HMBANA.

HMBASA. 2011. Guidelines for the Operation of a Donor Human Milk Bank in South Africa. pdf (accessed 08.04.2022).

Holy, O. & Forsythe, S. 2014. Cronobacter spp. as emerging causes of healthcare-associated infection. Journal of Hospital Infection, 86(3): 169–177. DOI:

Hunter, C.J. & Bean, J.F. 2013. Cronobacter: an emerging opportunistic pathogen associated with neonatal meningitis, sepsis and necrotizing enterocolitis. Journal of Perinatology, 33(8): 581–585. DOI:

Jeurink, P.V., van Bergenhenegouwen, J., Jiménez, E., Knippels, L.M.J., Fernández, L., Garssen, J., Knol1, J., Rodríguez, J.M. & R. Martín.2013. Human milk: A source of more life than we imagine. Beneficial Microbes, 4(1): 17-30. DOI:

Jones, C.A. 2001. Maternal transmission of infectious pathogens in breast milk. Journal of Paediatric and Child Health, 37:576-82 DOI:

Kalyantanda, G., Shumyak, L. & Archibald, L.K. 2015. Cronobacter species contamination of powdered infant formula and the implications for neonatal health. Frontiers in Pediatrics, 3: 56. DOI:

Karimi, M., Eslami, Z., Lotfi, M.H., Nori, S., Zandi, H., Taghipour-Zahir, S. & Akhondzardaini, R. 2013. Bacterial contamination of expressed breast milk in neonatal intensive care unit. Zahedan Journal of Research in Medical Science, 15(4): 48-52.

Lataf, D.L.A., Mahyudin, N.A., Rashedi, I.F.M., Hariri, R. & Abdullah, A.Z. 2020. Hazard Analysis and Critical Control Point (CCP) determination in cook-chilled beef curry and beef kurma. Journal of Tourism, Hospitality and Culinary Arts, 12(1): 456-473.

Law, B.J., Urias, B.A., Lertzman, J., Robson, D. & Romance, L. 1989. Is ingestion of milk-associated bacteria by premature infants fed raw human milk controlled by routine bacteriologic screening? Journal of Clinical Microbiology, 27(7):1560-1566. DOI:

Liston, J. 1998. Breastfeeding and the use of recreational drugs-alcohol, caffeine, nicotine and marijuana. Breastfeeding Review, 6(2): 27–30.

Lin, R., Shen, W., Wu, F., Mao, J., Liu, L., Chang, Y., Zhang, R., Ye, X., Qiu, Y., Ma, L., Cheng, R., Wu, H., Chen, D., Zheng, Z., Lin, X., Tong, X. & National Multicenter EUGR Collaborative Group. 2022. Human milk fortification in very preterm infants in China: A Multicenter Survey. Frontier in Pediatrics, (10): 795222. DOI:

Lucas, A., Cole, T.J., & Lucas, P.J. 1992. Breast milk and neonatal necrotising enterocolitis. Lancet, 339(8807): 1519-1523. DOI:

Mahirah, M. 2022. Pembangunan Sistem Keselamatan Makanan di Bilik Susu Unit Rawatan Rapi Neonatal (Ph.D). Universiti Kebangsaan Malaysia.

Malaysian Standard (MS 1480: 2007). Food safety according to Hazard Analysis and Critical Control Point (HACCP) system. Department of Standard Malaysia (First revision).

Mammina, C., Di Carlo, P., Cipolla, D., Casuccio, A., Tantillo, M., Plano, M.R., Mazzola, A. & Corsello, G. 2008. Nosocomial colonization due to imipenem-resistant Pseudomonas aeruginosa epidemiologically linked to breast milk feeding in a neonatal intensive care unit. Acta Pharmacologica Sinica, 29(12): 1486-1492. DOI:

Mangili, G. & Garzoli, E. 2017. Feeding of preterm infants and fortification of breast milk. Pediatria Medica e Chirurgica [Medical and Surgical Pediatrics], 39(2): 62-66. DOI:

Mense, L., Rößler, S., Hanusch, R., Roßberg, C. & Rüdiger, M. 2014. Bacterial contamination of mechanically extracted breast milk. American Journal of Perinatology, 31(4): 293-8. DOI:

MOH. 2010. Garis panduan pensijilan HACCP Dapur Hospital Kerajaan. Kementerian Kesihatan Malaysia.

Mohd Bakri, J., Maarof, A.G. & Norazmir, M.N. 2017. Confusion determination of critical control point (CCP) via HACCP decision trees. International Food Research Journal, 24(2): 747-754.

Montagne, D. Van Dael, P., Skanderby, M., Hugelshofer, W., 2009. Infant formulae powders and liquids, dairy powders and concentrated products, In: Dairy Powders and Concentrated Products. A.Y. Tamine (Ed.). Wiley, Chichester. pp. 294-331. DOI:

Nakamura, K., Kaneko, M., Abe, Y., Yamamoto, N., Mori, H., Yoshida, A., Ohashi, K., Miura, S., Yang, T.T., Momoi, N. & Kanemitsu, K. 2016. Outbreak of extended-spectrum β-lactamase-producing Escherichia coli transmitted through breast milk sharing in a neonatal intensive care unit. Journal of Hospital Infection, 92(1): 42-46. DOI:

NHS 2012. Guide to bottle feeding (accessed 07.27.2022).

NICE. 2010. Donor breast milk banks: the operation of donor milk bank services. NICE Clinical Guideline, 93. NHS, London.

Norrakiah, A.S., Masomeh, G., Salam, B.A., Kupusamy, U.P. & Norizan, J. 2014. Incidence of Cronobacter sakazakii in powdered infant formula milk available in Malaysia. Sains Malaysiana, 43(12): 1855-1863. DOI:

Novak, F.R., Das, A.V., Hagler, A.N. & Figueiredo, A.M.S. 2000. Contamination of expressed human breast milk with an epidemic multi-resistant Staphylococcus aureus clone. Journal of Medical Microbiology, 49(12): 1109–1117. DOI:

Ogundele, M.O. 2000. Techniques for the storage of human breast milk: implications for anti-microbial functions and safety of stored milk. European Journal of Pediatrics, 159(11): 793-797. DOI:

Park, J., Seok, W., Choi, B.J., Kim, H., Lim, B.K., Yoon, S., Kim, S., Kim, Y., & Park, J.Y. 2004. Salmonella enterica serovar London infections associated with consumption of infant formula. Yonsei Medical Journal, 45 (1): 43-48. DOI:

PATH. 2016. Strengthening Human Milk Banking: A Workshop for Developing a Hazard Analysis and Critical Control Points Plan for Your Human Milk Bank – Trainee Workbook. USA: 1.1.

PATH. 2019. Strengthening Human Milk Banking: A Resources Toolkit for Establishing and Integrating Human Milk Bank Programs – A Training Curriculum Template for Hospital and Human Milk Bank Staff. Seattle, Washington, USA.

Perez, P.F., Doré, J., Leclerc, M., Levenez, F., Benyacoub, J., Serrant, P., Segura-Roggero, I., Schiffrin, E.J. & Donnet-Hughes, A. 2007. Bacterial imprinting of the neonatal immune system: lessons from maternal cells. Pediatrics, 119(3): 724-732. DOI:

Roberts, S. & Severn, M. 1978. Bacterial growth in raw and pasteurised human milk. British Medical Journal, 2(6146): 1196. DOI:

Rozolen, C.D., Goulart, A.L. & Kopelman, B.I. 2006. Is breast milk collected at home suitable for raw consumption by neonates in Brazilian public neonatal intensive care units? Journal of Human Lactation, 22(4): 418-425. DOI:

Rowe, B., Begg, N.T., Hutchinson, D.N., Dawkins, H.C., Gilbert, R.J., Jacob, M., Hales, B.H., Rae, F.A. & Jepson, M. 1987. Salmonella ealing infections associated with consumption of infant dried milk. Lancet, 2(8564): 900-903. DOI:

Steel, C. & Short, R. 2008. Centralized Infant formula preparation room in the neonatal intensive care unit reduces incidence of microbial contamination. Journal of American Dietetic Association, 108(10): 1700-1703. DOI:

Stevens, E.E., Patrick, T.E. & Pickler, R. 2009. A history of infant feeding. The Journal of Perinatal Education. 18(2): 32-39. DOI:

Trautmann, M., Halder, S., Hoegel, J., Royer, H. & Haller, M. 2008. Point-of-use water filtration reduces endemic Pseudomonas aeruginosa infections on a surgical intensive care unit. American Journal of Infection Control, 36(6): 421-429. DOI:

Threlfall, E.J., Ward, L.R., Hampton, M.D., Ridley, A.M., Rowe, B., Roberts, D., Gilbert, R.J., Van Someren, P., Wall, P.G. & Grimont, P. 1998. Molecular fingerprinting defines a strain of Salmonella enterica serotype Anatum responsible for an international outbreak associated with formula-dried milk. Epidemiology and Infection, 121(2): 289-293. DOI:

Turck D. 2012. Safety aspects in preparation and handling of infant food. Annals of Nutrition and Metabolism, 60: 211-214. DOI:

Usera, M.A., Echeita, A., Aladueña, A., Blanco, M.C., Reymundo, R., Prieto, M.I., Tello, O., Cano, R., Herrera, D. & Martinez-Navarro, F.1996. Interregional foodborne salmonellosis outbreak due to powdered infant formula contaminated with lactose-fermenting Salmonella virchow. European Journal of Epidemiology, 12(4): 377-381. DOI:

Valens. 2022a. Carborie. (accessed 08.22.2022).

Valens. 2022b. Myotein. (accessed 08.22.2022).

Verma, G., & Yadav, A. 2018. Role of human milk fortifier on weight gain in very low birth weight babies. International Journal of Contemporary Pediatrics, 5(2): 353-358. DOI:

Wallace, A.W., Sperber, W.H. & Mortimores, S.E. 2011. Managing HACCP and Food Safety Throughout the Global Supply Chain. John Wiley & Sons, West Sussex. pp. 352.

Yamada, T., Nishida, H., Sakamoto, S., Okada, A., Sakanoue, M. & Suehiro, M. 1988. The effect of MCT oil suplement in very low birth weight infants, with evaluation by the 13c‐labeled MCT breath test. Acta Paediatrica Japonica, 30(5): 564-568. DOI:



How to Cite

Mohamad, M. ., Ishak, S., & Abdullah Sani, N. (2023). Identification of Sensitive Raw Materials at A Milk Preparation Room of A Neonatal Intensive Care Unit in the Canselor Tuanku Muhriz Hospital. Malaysian Applied Biology, 52(1), 109–121.



Research Articles