Unlocking Precision: Best Practices in Aliquoting / Sampling

What is Aliquoting?

Aliquoting is a key technique in pharmaceutical research to divide a larger volume of bulk material or reference materials into smaller quantities that are representative of the bulk. It unlocks precision, allowing for efficient use of resources while maintaining the integrity of samples.

The most common application of aliquoting is sampling - where a portion of bulk material is fractioned into smaller fractions while preserving the original bulk for future use. Sampled fractions are used for different analytical and microbiological tests such as: 

• Release testing per USP/NF/EP/JP/BP/ACS/FCC or custom methodology.
• Qualification or characterization studies for reference standard of drug substance and reference material
• Retesting for extension of material expiry
• Material identification and /or structural characterization studies

Aliquoting is also used to avoid repeated freeze-thaw or open-close cycles of materials, which helps prevent changes
in the physicochemical characteristics, such as easily oxidized chemistries, hygroscopicity, or light degradation. Division of bulk material and management of smaller quantities allows for preservation of the stock materials.  Other general applications of aliquoting are related to generation of fractions for storage or stability studies such as: 

• ICH Conditions to evaluate how material quality varies with time under the influence of environmental factors.
• Customizable Conditions to simulate specific field conditions that material can be exposed to during its life cycle.
• Photostability to measure the effect of light on material.
• Thermocycling study to determine material resistance to exposure to alternating extremes of high and low temperatures.
• Shipping Studies to assess the shipping configurations to endure the severities of transit.

Mastering Sample Integrity

Adhering to best practices is crucial to maintaining the quality and purity of samples during the aliquoting process:

• Environmental Controls: Properly designed workspaces and cleanrooms minimize contamination risks and operator exposure.
• Prevention of Cross-Contamination: Rigorous gowning, cleanroom etiquette, and precise cleaning routines help protect samples.
• Smart Equipment and Utensils: Single-use utensils and containers ensure sample purity and prevent cross-contamination.
• Monitoring for Quality: Routine environmental monitoring keeps track of contamination controls and facility conditions.

Crafting Best Practices 

Employing best practices in aliquoting not only ensures the quality and safety of samples, but also boosts efficiency and confidence in scientific outcomes:

• Avoiding Material Stress: Proper storage and handling prevent damaging repeated freeze-thaw cycles and open-close events.
• Optimizing Sample Size: Smaller, manageable portions offer better control for testing and analysis.
• Tracking Trends for Excellence: Regular monitoring of environmental data helps maintain consistency and prevent any deviations in quality.

The Bottom Line 

Aliquoting is more than just a technique – it is a precision tool in pharmaceutical science that plays a crucial role in ensuring the preservation of material quality and efficiency in processes. By dividing samples into smaller, manageable portions, operators can minimize the risk for contamination, preserve bulk material, standardize procedures, and streamline workflows. Adhering to best practices in aliquoting is essential for maintaining the integrity of samples and obtaining meaningful scientific results.

At Alcami, we offer custom aliquoting and sampling plans. Services are executed by qualified personnel in Grade C sampling booths adhering to Annex 1 requirements, guaranteeing the highest standards of quality and contamination controls.  Our services are tailored to your unique requirements, from retaining sampling to the implementation 
of acceptable quality levels (AQL), American National Standards Institute (ANSI), or custom sampling plans.

Learn more about Aliquoting/Sampling and GMP Pharma Storage at Alcami.