GE Healthcare Life Sciences is now Cytiva - Find out more

June 14, 2018

Baby formula story

By Gretchen Hathaway, Consumables Sales Specialist

Ensuring quality for babies everywhere.

For 10 years, Sebastián has worked as a Quality Control Manager at a nutritional plant in Mexico. He leads a team of lab technicians that produce high quality infant formula that is distributed daily on a global scale. But never has his work mattered more than when his wife Sofía gave birth to their son Sebastián Junior – what he does every day has a direct impact on the development and health of his own son.

Powdered infant formula – the manufacturing process

Sebastián starts the day with a coffee and catches up with his senior lab technician Matías, who gives him the quality control reports from the batches created that shift. Sebastián and his team produce powdered infant formulas, using a combination of both wet mixing and dry blending. In total, their manufacturing process has seven main steps:

  • Mixing of incoming premix
  • Pasteurization – protects against spoilage
  • Homogenization - increases emulsion uniformity & Stability by reducing size of fat and oil particles in formula
  • Standardization - tests key parameters (e.g., pH, fat concentration, etc.) to see if they are correct
  • Packaging
  • Sterilization
  • Stability testing

Premix quality control

There are several stages of manufacturing where baby formula must be checked for quality, starting with the premix. FDA regulations in the US require any manufacturer receiving ingredients from elsewhere to check the mix for minimum and maximum levels of nutrients, vitamins, and minerals. If an infant formula does not contain these nutrients within the specified range, it is considered an adulterated product. Some formula is "exempt" from these nutrient requirements, specifically "any infant formula which is represented and labeled for use by an infant who has an inborn error of metabolism or low birth weight, or who otherwise has an unusual medical or dietary problem" (FFDCA 412(h)(1). Source: Excerpted from Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 1, 2006).

Time saving and increased sample purity in analytical filtration

Analytical methods check for several analytes (e.g., nutrients such as proteins and carbohydrates; vitamins and minerals such as calcium, magnesium, and zinc). The biggest challenge faced by Sebastián and his team is that some analytes are hard to filter. For example, iodine is highly concentrated and must be diluted before filtering. Sebastián and his lab technicians follow the ICPMS method, which has been written in a different country and often causes problems. Lab technicians struggle to get the sample through the current polypropylene syringe filter they are using. Sebastián was relieved to revalidate and now uses a Whatman GD/XP Syringe Filter from GE Healthcare Life Sciences with a built-in polypropylene pre-filter, which helps his technicians process samples faster while maintaining sample purity.

For main process quality control, Sebastián and his team carry out a number of tests including HPLC, ICPMS, hygiene testing, and microbiology. This means his day is extremely busy, and he and his team are often left feeling as though they need more time. For example, when carrying out HPLC, many methods are used depending on the analyte. Extracting vitamin A, B, E, and K require different methods and different filters based on solvent compatibility. Sebastián and his team often dream about automation throughout this process.

Troubleshooting filtration: Revalidation

Perhaps the biggest pain point Sebastián faces across all quality control filtration is the difficulty of revalidating filters. Many methods followed are written in other countries and the filters validated into these methods often don’t work or aren’t well suited for the application. Straying from these methods would require significant revalidation and time constraints make it unrealistic. This also means that standardizing on filters is difficult. Autonomy and standardization are Sebastián’s strongest desire, and he is currently looking into standardizing all HPLC tests on GE’s Whatman brand regenerated cellulose filters due to its chemical compatibility with most components. Additionally, his team is investigating the use of an HPLC autosampler in conjunction with a syringeless filter device, such as a Mini-UniPrep with a regenerated cellulose membrane, autosampler, they can process more samples and still maintain sample flexibility.

Sebastián applies these tools and his trusted expertise and takes great pride in going home to take over the bottle feeds, giving his wife Sofía a much-needed rest.

Try our Whatman Filter Selector App to find out if you are using the most appropriate filtration solution for your samples. To discuss any challenges you are facing, please contact GE's Life Sciences Scientific Support.

*This story is representative and not based on an actual customer.