CASE STUDY

Aseptic SamplingProblem

Solution

Client: Dutch NutraceuticalsProblem: Inconsistent DataSolution: QualiTru Aseptic Sampling SystemResults: Consistency, Confidence and Profitability

The QualiTru team reviewed the clients current manufacturing process. It analyzed needs at both

the raw and finished silos along with the failure modes for each piece of

processing equipment. After obtaining a thorough understanding of the process

and improvements needed, the teams collaborated on a working plan

that addresses all concerns. Results

Dutch Nutraceutical Plant is Confident in Their Aseptic Sampling Process

Today, the team can trust the sample data collected across the entire manufacturing process and

produce a reliable product. Sample points included: rennet silos, lactose liquid load out and non-filtration verification. The

new standard QualiTru aseptic sampling ports and rigorous sample collection process allowed

understanding of what is happening in their system continuously. Having consistent

tools and methods reduces risks of different influences on sample

collection. The case for a comprehensive aseptic

sampling process was clear.

The Quality team could not properly evaluate their process

or their product because of unreliable and inconsistent data. Microbiological

data varied throughout the process. The team was challenged by not knowing if the

equipment and sanitation process was working properly due to the lack of data. They contacted

QualiTru for assistance to develop a plan to collect representative samples of raw

ingredients and finished products throughout the process. The new

sampling plan must provide accurate data, simple to use

and safe for employees.

After recognizing our samples were unreliable with unhygienic equipment, we are now confident using QualiTru ports to collect samples. — Quality Manager

The sample ports are easy to use and can easily be cleaned. Also, the instructions on how to replace and use is very easy to find and follow step by step. —Operations Manager