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Industries · Medicinal gases

Medicinal gases step by step.

Gases and gas mixtures in cylinders and bulk. Below: the path of one batch as the rules describe it, what MALUTI records at each step, and every record type these documents ask for — built or not yet.

The path of a batch

Medicinal gases in cylinders · EU GMP Annex 6 · 18 steps

Your certificate, line by line →

Pure oxygen

One gas and no formula. What is left is the gas batch, the filling batch and the cylinder.

An anaesthetic mixture

Two or more gases, each with its own batch and status, a declared proportion and a check that what came out is what was declared. Every cylinder is tested for every component, not one per cycle. Same shape as our own extraction.

Preparation

  • Trained people on the line

    Built in MALUTI

    Everyone in the manufacture and distribution of medicinal gases is trained on what applies to them, and the training is recorded.

    Annex 6 §5

  • The gas is a batch with a status

    Built in MALUTI

    Before filling, the batch of gas is determined, controlled against its specification and approved for filling.

    Annex 6 §22

  • The approved formula is on the site

    Built in MALUTI

    An approved, signed and dated formula, uniquely identifiable and with an effective date, listing every starting material with the amount of each.

    ch. 4 §4.17 and §4.3

  • Cylinder, vessel and valve are traceable

    Built in MALUTI

    A system that traces cylinders, mobile cryogenic vessels and valves. The valve is named separately, so it is a thing of its own.

    Annex 6 §29

  • A returned cylinder is prepared

    Built in MALUTI

    Evacuation and purging by a validated method, in line with the marketing authorisation, before the cylinder is refilled.

    Annex 6 §32

  • Eight checks before filling

    Built in MALUTI

    Residual pressure; previous batch labels removed; damaged labels replaced; external inspection; the outlet connection right for this gas; the valve test date; the hydrostatic test still valid; the colour code as the authorisation specifies.

    Annex 6 §30

Filling and checks

  • The filling manifold is dedicated

    Built in MALUTI

    A manifold is dedicated to one medicinal gas or to one given mixture, and the equipment used goes into the batch record.

    Annex 6 §14, §17(f)

  • The filling operation is a batch

    Built in MALUTI

    A batch is defined for filling, and its key filling parameters are recorded.

    Annex 6 §31, §17(i)

  • The mixing is validated

    Built in MALUTI

    The mixing process is validated to show that the gases are properly mixed in every cylinder and that the mixture is homogeneous.

    Annex 6 §38

  • Every gas that went in, with its status

    Built in MALUTI

    Batch references for the gas or gases used for the filling operation, including their status.

    Annex 6 §17(e)

  • Checked, leak-tested, sealed

    Built in MALUTI

    Each cylinder is checked as properly filled, leak-tested before the seal is fitted, then given a valve cover and a tamper-evident seal.

    Annex 6 §34, §35, §36

  • Every cylinder is labelled

    Built in MALUTI

    Each cylinder carries a label; the batch number and expiry may sit on a separate one. A specimen of the batch label goes into the batch record.

    Annex 6 §37, §17(k)

Release and dispatch

  • One cylinder per filling cycle is tested

    Built in MALUTI

    For a single gas, the gas from at least one cylinder of each uninterrupted filling cycle is tested for identity and assay.

    Annex 6 §40(b)

  • Every cylinder is tested, every component

    Built in MALUTI

    For a gas mixed in the cylinder, the gas from every cylinder is tested for assay and identity of each component gas.

    Annex 6 §40(c)

  • The batch is tested and certified

    Built in MALUTI

    Each batch is tested against the marketing authorisation and certified; the record carries the specification, the results and the calibration status behind them.

    Annex 6 §39, §17(l)

  • Deviations are signed off

    Built in MALUTI

    Every deviation from the batch record, with a signed authorisation.

    Annex 6 §17(n)

  • The authorised person certifies

    Built in MALUTI

    A statement of certification by the authorised person with date and signature, and who performed each significant step.

    Annex 6 §17(o), §17(d)

  • The cylinders leave protected

    Built in MALUTI

    Filled cylinders are protected in transit so they reach the customer clean and fit for the environment they will be used in.

    Annex 6 §45

What the rules ask, and what is built.

EU GMP Part I · EU GMP Annex 6, and the path of a batch above. 52 of 60 record types kept in MALUTI · 6 not built yet · 2 outside the software.

A record type in our catalogue is one thing a clause asks a site to record. Each is counted once, even when two documents or a step of the path ask for it. “Kept in MALUTI” covers what MALUTI does itself and the record it keeps of work your site does. The count shows what we have mapped, not a share of the regulation.

Not built yet (6)

  • Keep a visitor policy with classes of person EU GMP ch. 2 §2.13
  • Use only starting materials that Quality Control has released EU GMP ch. 5 §5.34
  • Clear the work area and equipment before a processing operation starts EU GMP ch. 5 §5.40
  • Record who took material out of store for a run EU GMP ch. 5 §5.37
  • Derive the exposure limits behind a shared line EU GMP ch. 5 §5.20
  • Hold the periodic management review of the quality system EU GMP ch. 1 §1.6
Built in MALUTI (49)ShowHide
  • Record what a person is qualified by EU GMP ch. 2 §2.1
  • Keep the record of a consultant: name, address and service EU GMP ch. 2 §2.23
  • File fitness for work EU GMP ch. 2 §2.16
  • Record training and its expiry EU GMP Annex 6 §5
  • Assess periodically whether training actually worked EU GMP ch. 2 §2.11
  • Keep training programmes approved by the head of Production or of Quality Control EU GMP ch. 2 §2.11
  • Grant access to rooms EU GMP ch. 3 §3.5
  • Keep an organisation chart showing who answers to whom EU GMP ch. 2 §2.2
  • Write down the duties and the authority of a responsible position EU GMP ch. 2 §2.3
  • Declare what each room must hold, and watch it EU GMP ch. 3 §3.19
  • Register equipment and its qualification EU GMP ch. 3 §3.34, §3.41
  • Keep the use and cleaning log of each machine EU GMP ch. 4 §4.31
  • Examine each container: labels, damage, broken seals EU GMP ch. 5 §5.30
  • Run an identity test on every batch received EU GMP ch. 5 §5.35
  • Hold incoming material in quarantine until released EU GMP ch. 5 §5.5
  • Hold the approved manufacturing formula, with its versions and its effective date EU GMP ch. 4 §4.17, §4.3
  • Define a process as data, with its limits EU GMP ch. 4 §4.18
  • Start and run a process EU GMP ch. 4 §4.20
  • Investigate a significant deviation from expected yield EU GMP ch. 5 §5.44
  • Run an on-going stability programme EU GMP ch. 6 §6.27–6.31
  • Trend results and investigate what falls outside EU GMP ch. 6 §6.9, 6.35
  • Raise and close deviations EU GMP ch. 5 §5.15
  • Run CAPA through action and verification EU GMP ch. 1 §1.4(xiv)
  • Raise an incident and find the batches around it EU GMP ch. 8
  • Record a complaint from outside: who complained, what was answered, and what happened to the batch EU GMP ch. 8 §8.5–8.14
  • Run self-inspection to a programme EU GMP ch. 9
  • Approve and supersede procedures EU GMP ch. 4
  • Register counterparties and score suppliers EU GMP ch. 7
  • Compile the annual product quality review EU GMP ch. 1 §1.10
  • Recall released product EU GMP ch. 8 §8.22–8.30
  • Control packaging materials and their storage EU GMP ch. 5 §5.46
  • Clear the line before packing, and record it EU GMP ch. 5 §5.50
  • Issue, reconcile and destroy labels EU GMP ch. 5 §5.46, §5.61, §5.62
  • Record a batch that came back: from whom, how much, why, and what was done with it EU GMP ch. 5 §5.70
  • Assemble a batch dossier EU GMP ch. 4
  • Calibrate instruments against a schedule EU GMP Annex 6 §17(l)
  • Approve a specification, every limit naming its method EU GMP Annex 6 §17(l), §39
  • Take a sample to a sampling plan EU GMP Annex 6 §40
  • File a certificate of analysis and let it be judged EU GMP Annex 6 §39
  • Keep the risk matrix and the validation file EU GMP Annex 6 §38
  • Release a batch EU GMP Annex 6 §17(o)
  • Register a cylinder, its valve and the dates its tests run out EU GMP Annex 6 §29
  • Prepare a returned cylinder before it is refilled EU GMP Annex 6 §32
  • Run the eight checks before filling, and record each answer EU GMP Annex 6 §30
  • Record every cylinder of the filling batch, filled or rejected EU GMP Annex 6 §17(g), §17(j), §17(m)
  • Print a label carrying the seven required fields EU GMP Annex 6 §37, §17(k)
  • Monitor conditions in transit EU GMP Annex 6 §45
  • Dispatch a consignment through the gate checks Lesotho LN40 reg. 24 · path step Annex 6 §45
  • Seal so the receiver is alerted to tampering EU GMP Part II 9.46 · path step Annex 6 §45
Done by the site, recorded in MALUTI (3)ShowHide
  • Maintain buildings, floors, lighting, changing rooms EU GMP ch. 3 §3.2, §3.3, §3.31
  • Control pests in storage, by authorised people only EU GMP ch. 3 §3.4
  • Hold written contracts for outsourced work EU GMP ch. 7 §7.14–7.17
Outside the software (2)ShowHide
  • Examine a person medically and read the finding EU GMP ch. 2 §2.16
    The examination is a doctor's work and the finding is medical. We hold the outcome in three words, the dates and who recorded them. A field for a diagnosis does not exist anywhere in this system, because a record that only ever grows cannot take a disclosure back.
  • Run the analysis itself EU GMP ch. 7
    The laboratory has its own accreditation, its own methods and its own instruments. We hold the certificate and its hash, the limits it was judged against, the verdict, and the state of that laboratory's licence on the day it signed.

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