Solentim offers a risk-based approach to technology integration within Quality environments – designed to be pragmatic and appropriate yet scalable as your company grows. We also recognise the individual needs of customers so welcome your email to [email protected] to start this discussion.

Learn more about the following areas:

Installing quality from the start: the value of Installation Qualification and Operational Qualification (IQ/OQ)

Solentim has a comprehensive commitment to address all aspects of the Quality driven instrument validation process. This service is carried out by our specially trained engineers and offers both Installation Qualification (IQ) and Operational Qualification (OQ).

IQ is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument.

OQ is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the selected environment.

To learn more, email [email protected]

Why a Part 11 ‘mind set’ should be a foundation to every cell line development workflow

“The intent of both Part 11 pieces is to best manage the security of electronic records, record attribution of work and define the use of electronic signatures. This design methodology is frequently described as a ‘closed system’ where all interactions with data (production, changing, removal) are audited and protected from external influence.”

Learn more about 21 CFR Part 11 and EU Annex 11

Clonality in stem cell derived therapies, a journey from process development to manufacturing

“Emergent companies in this space have an eye on the future production of clinical treatments. Whatever the timescale, the question of when and how to implement practices that will be scalable to cGMP (current Good Manufacturing Practice) often arise.”

Learn more about current Good Manufacturing Practice

Sterile VIPS Consumable Project Kits available for single project use

Consumable parts needed for use with VIPS for single-cell seeding are now supplied as sterile kits for single project use. Use these kits to ensure a sterile set of consumables for each new project, and to significantly speed up the cell seeding process by elimination of the sterilization procedure. Two kits are available, including either V1 or V2 cell reservoir nozzles.

To learn more about the kits, please email [email protected]