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Sterile injectablesCovers the Annex 1 controls

Sterile injectables manufacturing software that checks before every aseptic step.

Swat iQua Suite gives parenteral plants a server-side gate on every sterile step — gowning, cleanroom status, open EM excursions and media-fill validity — plus controlled records for sterilisation, filter integrity, lyophilisation, container closure integrity and visual inspection.

  • Sterile step gate on the eBMR
  • Media fill with line qualification
  • Sterilisation cycles with BI/CI and SoD release
  • Failures raise deviations and release blockers
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Operators in sterile cleanroom garments at a filling line

The sterile step gate

Four checks before any aseptic step can start.

Sterile batches run on the same eBMR engine as the rest of the plant. On every sterile step, Swat iQua Suite checks the evidence on the server — not on a poster by the door.

  1. PersonnelGowning

    Operator gowning current

    The operator must hold a current gowning qualification, recorded with an e-signature by a different assessor.

    Qualified

  2. RoomCleanroom

    Cleanroom ready and qualified

    The room recorded on the step must be qualified and ready for use.

    Ready

  3. EMExcursions

    No open EM excursion

    An open action-limit excursion in the room stops the step until it is dispositioned.

    None open

  4. LineMedia fill

    Current passing media fill

    The filling line must have a passing aseptic process simulation that is still within its validity period.

    Valid

Each check applies when the room and line are recorded on the step; the cleanroom and aseptic line are captured at step start.

Sterile modules

The records behind the gate.

Sterile modules appear only at sites where the sterile feature is switched on — so a mixed site keeps oral and sterile operations on one platform without clutter.

  • Media fill (APS)

    Versioned protocols and runs; any positive unit means fail, and a passing run sets the line’s valid-until date.

    Aseptic process simulation

  • Sterilisation & filter integrity

    Moist heat, dry heat, depyrogenation, gas, radiation and filtration cycles with BI/CI results and SoD release; pre- and post-use filter tests.

    Sterilisation cycles

  • Contamination control strategy

    The site’s CCS with a hazard → control → monitoring → effectiveness register, approved and versioned.

    Contamination control strategy

  • Utilities monitoring

    WFI, clean steam, compressed air and HVAC results classified against versioned alert and action limits.

    Utilities monitoring

  • Environmental monitoring

    Cleanrooms, monitoring points, gowning qualifications and excursion disposition with versioned limits.

    Environmental monitoring

  • Sterile batch release

    Sterility, endotoxin and media-fill items on the release checklist, with sterile failures raised as release blockers.

    Batch release

Parenteral process records

Lyophilisation, visual inspection and container closure integrity.

The records that follow filling are where many sterile plants still rely on paper printouts and spreadsheets.

Lyophilisation cycles

Freeze-dry recipes hold the set points for freezing, primary drying and secondary drying with their acceptance criteria, and are approved with segregation of duties and an e-signature. Each cycle is linked to its equipment and batch. Shelf temperature, vacuum and time are entered per phase and checked against limits; an out-of-limit entry raises a deviation, and corrections supersede the original value. The operator cannot approve their own cycle.

Visual inspection

Inspection runs are recorded per batch or finished-goods lot, as 100% inspection or AQL sampling with the AQL level recorded. Units inspected and rejected are captured with a defect breakdown by category. The accept or reject decision is made by someone other than the inspector, with an e-signature, and a reject raises a deviation and a release blocker.

Container closure integrity testing

CCIT results are recorded per batch or lot with container type, method, sample size, acceptance criteria and supporting attachments, then verified by a second person. A failed test raises a deviation and a critical release blocker on the batch.

When something fails

Sterile failures do not wait for someone to notice. A failed biological or chemical indicator stops a sterilisation cycle from being released; a failed filter integrity test, media fill, CCIT result or visual inspection reject raises a deviation and blocks batch release until it is resolved or covered by an approved, documented exception.

EU GMP Annex 1 expects a contamination control strategy, qualified personnel, environmental and utilities monitoring, validated sterilisation, aseptic process simulation and integrity testing. Swat iQua Suite covers the Annex 1 controls for each of these areas — the strategy and procedures remain yours.

Sterile batch release

Every sterile failure reaches the release dossier.

The release checklist adds sterile-only items, and sterile failures from across the platform arrive as blockers — so QA sees the whole picture before signing.

  • Sterile checklist items — sterility, endotoxin and media fill satisfactory, alongside BMR, QC, CoA and deviations.
  • Automatic blockers — from BI/CI, filter integrity, CCIT, visual inspection and media fill failures.
  • EM excursions — an excursion disposition raises a deviation and a critical release blocker.
  • SoD release — the batch executor can never be the QA releaser.
Batch release software
Batch release dossier with sterile checklist items and review status

Rollout

Bring sterile controls online in a sensible order.

Licensing is modular, so you can phase sterile modules in. A typical sequence:

  1. Step 1

    Cleanrooms & EM

    Register cleanrooms and monitoring points, approve limits and record gowning qualifications.

  2. Step 2

    Media fill

    Approve APS protocols and record runs so every aseptic line has a current qualification.

  3. Step 3

    Sterilisation & filters

    Move cycle records, BI/CI results and filter integrity tests into the system.

  4. Step 4

    Sterile eBMR

    Switch on the sterile step gate so aseptic steps check gowning, room, EM and media fill.

  5. Step 5

    Lyo, CCIT, inspection & CCS

    Add lyophilisation, CCIT, visual inspection, utilities and the contamination control strategy.

Designed to comply with

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Related

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

Is Swat iQua Suite Annex 1 compliant?

Software alone cannot be compliant. Swat iQua Suite covers the Annex 1 controls for contamination control strategy, personnel gowning, environmental and utilities monitoring, sterilisation, aseptic process simulation and integrity testing; your site’s procedures and validation complete the picture.

What stops an operator starting an aseptic step?

The sterile step gate checks that the operator’s gowning qualification is current, the cleanroom is ready and qualified, there is no open EM excursion in the room and the line has a current passing media fill. If any check fails, the step cannot start.

Does the system calculate AQL sample sizes?

No. Visual inspection records whether a run used 100% inspection or AQL sampling and the AQL level used, together with units inspected, rejects by defect category and an e-signed decision. Sample sizes come from your own procedure.

Can we run sterile and non-sterile products on one installation?

Yes. Sterile modules sit behind a per-site sterile feature, and the sterile gate applies only to sterile batches, so mixed sites use one platform.

Are lyophilisation parameters captured automatically from the dryer?

Per-phase values such as shelf temperature, vacuum and time are entered against the cycle and checked against the recipe limits. Out-of-limit values raise a deviation automatically.

Ready to see Swat iQua Suite in action?

Book a free, personalised demo and see how Swat iQua Suite takes your plants, labs and quality teams from paper to inspection-ready.

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