Particle Analytical - Expert Particle Characterization Laboratory

Particle Analytical is a GMP contract laboratory that can provide you with all the analytical services within particle characterization. This field is a highly specialized area that requires a lot of expensive equipment, as well as highly trained professionals. The area of particle characterization is especially important in cases of poorly soluble substances and also in cases of multiple suppliers.

Also it is essential to have a well-documented and properly developed method to describe the actual product. We can assist you in defining the critical parameters for your product, develop the proper method and assure that you get the right quality.

PARTICLE SCIENCE SUPPORT

PA is devoted to supporting customers within the field of particle science. We focus on the pharmaceutical industry and perform all analysis according to GMP. We have been inspected by FDA and hold a GMP certificate from Danish Medicines Agency (DKMA). Our services are relevant for discovery, development and quality control.

TAILORED PARTICLE LABORATORY SOLUTIONS

As a contract laboratory we aim to provide you with tailored solutions to meet your needs. We can offer online access to results saving time for communication and making the documents easily accessible for future reference and internal distribution.

We have the following techniques available

• Laser diffraction, Malvern wet and dry
• Optical microscopy with digital image analysis
• SEM with EDX (mapping of elements)
• BET with N2 or Ar (total specific surface area)
• Dynamic light scattering (nanoparticles)
• DSC (Differential Scanning Calorimetry)
• Air permeability (specific surface area)
• Helium pycnometry
• Mercury porosimetry
• Bulk and tapped density
• Flowability
• XRD (Powder x-ray diffraction, non GMP)

PARTICLE SCIENCE VALIDATION

We are experts in method development and validation. We perform your routine analysis and can also offer next day services. Our contract services are relevant in the following areas:

• Patents - not violating others and complying with own
• Development - defining suitable quality and setting specifications
• Regulatory affairs - compliance through documentation and validations
• Purchase - setting specifications, ensuring quality continuity, solving complaints and transferring, method supplier takes risk at non compliance
• Quality - ensuring quality continuity, investigate failures
• Operations - consistent production in correct quality, ensuring supply capabilities in correct quality and logistic optimization – correct products on stock
• Sales - ensuring correct product from you at correct time
• Legal - avoiding lawsuits

ICH-COMPLIANT PARTICLE CHARACTERIZATION

According to ICH Q6A specifications, it is clear that there are well-developed requirements to be considered when implementing particle characterization, and we have the skills to advise on these.

PARTICLE CHARACTERIZATION

Physical characterization is critical for poorly soluble substances regarding bioequivalence. The characterization ensures that the API used for future production meets the exact specification for the API originally accepted. For particle characterization it is important to remember that the result depends on method of analysis.

This is important since specifications are based on a specific method and that only one method is given to the authorities. Using multiple suppliers with different methods makes it critical for you to define your own standard in terms of analysis. You are responsible for ensuring that the product complies with the specifications using the method given to authorities.

The quality of this method is therefore of utmost importance from a commercial point of view, and also since authorities are becoming more aware of regulatory requirements and safety issues.