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Pharmaceutical and Nutraceutical

Life Sciences solutions for the pharmaceutical and nutraceutical sector

Cleanrooms, laboratories and regulated environments for critical manufacturing processes, quality control and operational continuity.

Pharmaceutical and nutraceutical processes require environments designed around the product, the operations and the applicable requirements. Contamination control, air quality, flow management and operational continuity contribute to process quality.

Mangini Life Sciences develops turnkey solutions for cleanrooms, laboratories and controlled contamination environments, supporting clients from requirements definition through design and construction to qualification, validation and operational continuity.

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Regulated environments for product protection, process and production continuity

In manufacturing, packaging and quality control environments, the design must translate process needs into defined, verifiable operating conditions.
Layout, personnel and material flows, air handling, differential pressures and monitoring are defined according to the activity. Sterile processes and non-sterile or nutraceutical production have different needs, each requiring a specific assessment.

Key needs

Particulate and microbiological control

Reduced risk of cross-contamination

Management of personnel, material and product flows
Monitoring of temperature, humidity, pressure and particulate contamination
Support for commissioning, qualification and validation
Operational continuity and long-term maintenance

Related solutions

Controlled contamination environments designed to protect product and process.
Technical spaces dedicated to analysis, testing and monitoring of process parameters.

Environments designed for activities requiring high levels of control, safety and documentation.

Off-site and modular solutions to accelerate the delivery of new regulated environments or production expansions.

Support for the documentation process, system verification and operational continuity after handover.

Compliance by Design for pharmaceutical and nutraceutical environments

The requirements framework is defined at project start-up according to the product, the process and the target market. For pharmaceutical activities, the applicable GMPs are taken into account; for nutraceuticals, the requirements relevant to the specific production are identified.

Standard and references

  • EU GMP applicable to the pharmaceutical process; Annex 1 for the manufacture of sterile medicinal products, where relevant.
  • ISO 14644 series, for the aspects applicable to cleanrooms.
  • Microbiological contamination control criteria defined according to the process.
  • Target market requirements, including FDA requirements where applicable.
  • Qualification of systems and equipment and validation activities within the agreed scope, including IQ/OQ/PQ where required.

Standard e riferimenti

Do you have a pharmaceutical or nutraceutical project to develop?

Tell us about the type of environment required, the project stage and the applicable standards. Mangini Life Sciences will assess the first technical areas to explore.
Request a preliminary assessment