Product

Cleanroom & Biosafety

Controlled environment infrastructure and equipment.

Name: Cleanroom & Biosafety
Brand: KAPSAM

Modular cleanroom, biological safety cabinets and laminar flow cabinets.

Configured to the workflowSet up for the preparation in scope, not a generic installation.

Software-guided stepsOrder entry, calculation and guided preparation.

KAPSAM sterile disposablesFluid paths produced in ISO 14644 compliant cleanrooms.

Installation and serviceCommissioning, user training and technical support.

Overview

What this product does

Controlled environment infrastructure planned against the preparation workflow it supports, covering modular cleanroom construction, biological safety cabinets and laminar flow cabinets.

Benefits

Designed around the workflow

Modular Cleanroom

Room construction planned for the classification in scope.

BioSafety Cabinet (BSC)

Containment for the application.

Laminar Flow Cabinet

Airflow for the intended process.

In action

Installed as part of a project that also covers the workflow running inside the environment.

Software

Workflow software and connectivity

Monitoring scope is defined during project assessment.

Consumables

Related sterile components

Filters

Technical

Specification and regulatory information

Classification, airflow data and qualification scope are published once Technical Solutions and Quality review is complete.

Request information on Cleanroom & Biosafety

Where this fits

Workflows this supports

Parenteral Nutrition CompoundingPatient-specific PN admixturesOncology CompoundingHazardous IV chemotherapyCentral IV CompoundingCentralised IV admixturesInfusion & Sterile CompoundingInfusion and sterile componentsCleanroom & BiosafetyControlled environmentsWaste ManagementHazardous waste containment

Documents

Brochures, certificates and technical information

Catalogues & brochures

Product documents available to download.

Quality certificates

ISO, CE and conformity documentation.

Request information

Ask for the documentation released for your market.

Questions

Frequently asked questions

The answers below cover what hospital pharmacy, IT and technical teams ask most often. If your question is not here, our team will answer it directly.

Does the system integrate with our hospital information system?

Yes. KAPSAM systems exchange order and preparation data with HIS/EHR environments through HL7 and API integration, scoped per project with your IT team.

Which consumables are used with the system?

KAPSAM manufactures the sterile disposables used in the fluid path, including EVA bags, IV lines, filters and administration sets, assembled and sterilised in ISO 14644 compliant cleanrooms.

What training and service is provided after installation?

Installation and commissioning, on-site or virtual user training, preventive maintenance and technical support are provided by the KAPSAM service team or a trained distributor partner.

Which certificates are available for the product?

KAPSAM operates ISO 13485:2016, ISO 9001:2015 and ISO 14001:2015 certified systems and is audited by a notified body (CE 0425). Certificates can be downloaded from the Quality page.

Discuss this product with our team

Tell us about your application area, preparation volume and hospital systems. We will respond with the relevant technical and project information.