Compliance is at the core of our instruments designed for the bioprocessing industry.
Pharmaceutical companies are required to meet specifications for the excipients, drug substances, and final drug products.
These specifications should meet the quality standards in the:
Compendial pharmacopeial tests are standardized protocols for many pharmaceutical raw materials and finished products.
The OsmoTECH portfolio of osmometers meets osmolality testing guidelines stated in the above mentioned pharmacopeias. Ensuring the quality of products manufactured, released, and distributed globally in the biopharmaceutical industry.
Data integrity is the completeness, consistency, and accuracy of data. In the pharmaceutical and biotechnology industries, this can be achieved by ensuring the trustworthiness and reliability of electronic records.
The OsmoTECH portfolio of osmometers and the Artel portfolio of liquid handling calibration and verification instruments help you maintain compliance with built-in data integrity features that help support 21 CFR Part 11 and EU Annex 11 regulations.
Some features include:
In the world of liquid handling devices, whether your company needs to comply with legal requirements from regulatory agencies, or voluntarily aligns its processes to published consensus standards, your lab will benefit from increased productivity, higher quality results, and easier audits.
In both cases, there are two ISO standards and one ASTM standard important to note: ISO 23783 for automated liquid handlers, and ISO 8655, as well as ASTM E1154 for manually-operated liquid handling devices. The new ISO 23783 series was published in 2022, and major revisions to ISO 8655 and ASTM E1154 were published in 2022 and 2023, respectively.
Definitions, requirements and acceptable methods for measuring the volumetric performance, including dual-dye ratiometric photometry, are described in ISO 23783 Part 2 for automated liquid handlers, and in ISO 8655 Parts 7 & 8, as well as in ASTM E1154 for manually-operated liquid handling devices. Training requirements for pipette operators are described in ASTM E1154. Our Artel portfolio of liquid handling calibration and verification products, services, and trainings can help you conform to these standards.
As safety and efficiency of a product are crucial in cell therapy, we are focused on providing the highest levels of hardware, software, consumables and service to ensure our solutions are GMP-ready.
The STUDIUS Powered Ecosystem delivers a consistent workflow when creating Master Cell Banks by incorporating critical data from VIPS® PRO single cell seeding and Cell Metric® X clone verification and colony outgrowth monitoring. The platform enables seamless data analysis across multiple instruments, eliminating a tedious and error-prone review of spreadsheets, while maintaining data integrity and traceability, and preparedness to be used in 21 CFR Part 11 compliant environments.
MatriClone contains the recombinant laminin-511 E8 protein fragment, the same component found in clinical grade laminin products, ensuring quality and consistency across your research and GMP iPSC workflows when combined with VIPS PRO’s GMP-certified single use consumables.
Get the best performance from your Solentim instruments from the people who designed and built them. We provide a range of services and service plans to meet the different needs of our customers.
Our certified Field Service Engineers provide on-site professional support for the installation, training, validation, and maintenance of your equipment.
Learn moreIf you have any questions about Bioprocessing Compliance & Conformity or are interested in learning more, please ask!
Contact UsSam Murray
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Director, RAQA & Service