Pharmspec - High Quality
Formed due to mechanical stress or temperature changes.
Why do pharmaceutical companies choose Pharmspec?
In the highly regulated world of pharmaceutical manufacturing, "good enough" doesn't cut it. When you are testing parenteral products for sub-visible particle content, the margin for error is zero. This is where PharmSpec Software , developed by Beckman Coulter, becomes an indispensable asset for your lab.
Headquartered in New Jersey, Pharmspec has carved out a niche as a reliable alternative to expensive "Big Pharma" machinery brands, offering equipment that balances performance with capital expenditure efficiency. pharmspec
| Component | Description | |-----------|-------------| | | Confirmation that the material is what it claims (e.g., FTIR, HPLC retention time). | | Purity | Limits for impurities, degradants, residual solvents, and heavy metals. | | Potency / Assay | Active pharmaceutical ingredient (API) content (% of label claim). | | Uniformity | Consistency of dosage units (weight, content uniformity). | | Dissolution | Rate of drug release from solid dosage forms. | | Microbial limits | Control of bacteria, fungi, and pathogens. | | Physical properties | Particle size, hardness, friability, pH, viscosity. |
Modern LIMS with PharmSpec functionality allow:
If left unmonitored, these particles can trigger adverse immunogenic responses in patients or indicate that a drug is degrading. How PharmSpec Works: Precision and Compliance Formed due to mechanical stress or temperature changes
Investing in PharmSpec isn't just about buying software; it's about gaining peace of mind. By automating the most tedious parts of particle counting and strictly adhering to global compliance standards, PharmSpec allows your team to focus on what matters most: ensuring product quality and patient safety.
Sub-visible particles (typically those between 2 µm and 100 µm) are a major concern for biotherapeutic products like monoclonal antibodies (mAbs). While they are too small to be seen by the naked eye, these particles can include:
This is the backbone of their offering, catering to tablet and capsule production. When you are testing parenteral products for sub-visible
As particles pass through the laser, they cast shadows that the software interprets to determine particle size and concentration.
Modern versions of the software integrate with Windows logon, removing the need for separate, hard-to-manage user lists.