SteriTrend
Industries

Environmental monitoring in the hospital pharmacy

For the aseptic preparation of parenterals and cytotoxics: monitoring, operator validation, deviations and trending in one application.

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Trusted by, among others

Kepler University HospitalFriedrich-Ebert-Krankenhaus NeumünsterSK ApothekenHeidelberg University Hospital
Requirements

What aseptic preparation demands.

Hospital pharmacies preparing aseptically have to monitor environment, staff and processes without gaps – and demonstrate it at every inspection.

Air, surfaces, personnel

Regular samples from room air, surfaces and gloves are part of daily routine. Every result is documented and assessed against warning and action limits.

Validated staff

Anyone preparing aseptically demonstrates it regularly with manufacturing simulations. Expiring validations must not slip through the cracks in shift work.

Ready for inspection

Trends, deviations and the actions taken must be available at any time – not scattered across paper binders and Excel lists.

How SteriTrend supports your hospital pharmacy.

Mibi →

Sample plans in a daily view, barcodes from label to reading, an incubation timer that logs the actual incubation time, and the release process with digital signature.

Trends & Reports →

Trend analyses according to Annex 1, charts and reports with metrics such as the contamination rate – easy to print and at hand for regulatory audits.

Deviations →

An automatic event for every limit exceedance – with root cause analysis, actions with due dates and a deviation report.

Validation →

Initial validation and revalidation after manufacturing simulations, automatically; reminders of expiring validations; plus in-use validations and positive controls.

Companion app →

Scan samples right in the cleanroom and the lab, print labels and upload photos – on your phone or tablet.

Questions

Frequently asked.

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Is SteriTrend suitable for environmental monitoring in a hospital pharmacy?
Yes. SteriTrend is built for the aseptic preparation of parenterals and cytotoxics: sample plans, operator validation, deviations and trend analyses according to Annex 1 in one application. Whether you prepare under national pharmacy regulations – in Germany the Pharmacy Operations Ordinance (ApBetrO) and the Federal Chamber of Pharmacists’ guideline – or hold a manufacturing authorisation under the EU GMP Guide including Annex 1, SteriTrend maps the documentation and evaluation of your monitoring in a GMP-compliant way with an audit trail. The professional assessment remains with you.
Is SteriTrend already in use at hospitals?
Yes. SteriTrend is in use at Kepler University Hospital, Heidelberg University Hospital and Friedrich-Ebert-Krankenhaus Neumünster, among others.
Can I keep using my existing printers or scanners with SteriTrend?
Yes. You can keep using your existing label printers and barcode scanners – no special integration is needed, so there is no need to buy new hardware.
What happens when a result exceeds a limit?
SteriTrend automatically creates an event and notifies you by email or as a message in the system. You document root cause analysis, risk assessment, actions and the deviation report directly on the event.
Do we need to install software?
No. SteriTrend is web-based, which means you simply open it in your web browser – just like a website. For work directly in the cleanroom and the lab there is also the companion app for phone and tablet.
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In a roughly 60-minute demo we show you SteriTrend based on the workflows of your hospital pharmacy.

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