{"id":15,"date":"2026-10-12T06:37:34","date_gmt":"2026-10-12T06:37:34","guid":{"rendered":"https:\/\/fgvhp.com\/applications\/cell-gene-therapy\/"},"modified":"2026-10-12T06:37:34","modified_gmt":"2026-10-12T06:37:34","slug":"cell-gene-therapy","status":"publish","type":"page","link":"https:\/\/fgvhp.com\/ru\/applications\/cell-gene-therapy\/","title":{"rendered":"VHP \u0432 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435 \u043a\u043b\u0435\u0442\u043e\u0447\u043d\u043e\u0439 \u0438 \u0433\u0435\u043d\u043d\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438"},"content":{"rendered":"\n\n
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Home<\/a> \/ Applications<\/a> \/ Cell & gene therapy<\/span><\/div>\n Application \u00b7 Cell & gene therapy<\/span>\n

VHP in Cell and Gene Therapy Manufacturing<\/h1>\n

Cell therapies cannot be terminally sterilised, and each batch is often a single patient. Decontamination between batches has to be reliable, fast enough for the schedule, and leave nothing behind that could harm living cells.<\/p>\n

Request a Free Application Review<\/a><\/div>\n <\/div>\n
\"Fenggu<\/div>\n<\/div><\/section>\n\n
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The challenge<\/span>

Why this needs a VHP step<\/h2><\/div>\n

Open manipulations, frequent changeovers and many products in one facility make cross-contamination the central risk. Every batch change needs a documented decontamination of the closed processing environment.<\/p>

Hydrogen peroxide is effective and leaves only water and oxygen, but cells are sensitive to oxidative stress. The aeration end-point and the materials left in the chamber matter more here than in most applications.<\/p><\/div>\n<\/div><\/section>\n\n

\n Typical configuration<\/span>

Equipment options<\/h2>\n
FG-ISO-CC<\/span>

Cell processing isolator<\/h3>

Closed Grade A environment integrating centrifugation and CO\u2082 incubation, with dry VHP decontamination between processes and temperature control during the cycle. DQ, IQ, OQ and PQ support, including VHP culture-vessel penetration confirmation.<\/p>View specifications \u2192<\/span><\/a>FG-PB-VHP<\/span>

VHP pass box<\/h3>

Decontaminates the outside of consumables and reagent containers as they enter the processing area.<\/p>View specifications \u2192<\/span><\/a><\/div>\n \n<\/div><\/section>\n\n

\n Engineering & validation<\/span>

What to plan for<\/h2>\n
01<\/span>

Set the residual target from the cells<\/h3>

Operator-safety limits are not the right end-point when cells follow. Define an acceptable residual for the process and confirm the aeration time reaches it with the real load.<\/p><\/div>

02<\/span>

Plastics hold peroxide<\/h3>

Single-use bags, tubing and culture vessels absorb and slowly release H\u2082O\u2082. Decide what stays in the chamber during the cycle and what comes in afterwards through a transfer device.<\/p><\/div>

03<\/span>

Temperature during the cycle<\/h3>

Cycle temperature should not stress incubators or equipment inside the isolator. Temperature control during the cycle is part of the specification.<\/p><\/div>

04<\/span>

Changeover time is a capacity limit<\/h3>

With single-patient batches, the decontamination cycle often sets how many batches a line can run. Optimise aeration with the real load early.<\/p><\/div>

05<\/span>

Segregation between products<\/h3>

Separate micro-environments and docking incubators help keep different cell lines apart. Include each configuration in the qualification.<\/p><\/div><\/div>\n<\/div><\/section>\n\n

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Before you ask for a quote<\/span>

Information an engineer will need<\/h2>

Having these ready makes the first recommendation specific instead of generic.<\/p><\/div>\n

  • Process steps inside the isolator<\/li>
  • Single-use materials present during the cycle<\/li>
  • Batches per week and changeover window<\/li>
  • Acceptable residual for the process<\/li>
  • Incubators and equipment to integrate<\/li>
  • Regulatory market (FDA, EMA, NMPA)<\/li><\/ul>\n<\/div><\/section>\n\n\n
    \n FAQ<\/span>

    Common questions<\/h2>\n
    Will VHP residue harm my cells?<\/summary>

    Hydrogen peroxide breaks down to water and oxygen, but low residual levels can affect sensitive cells. The aeration end-point should be set for the process and confirmed with the actual load.<\/p><\/details>

    Can culture vessels stay in the isolator during the cycle?<\/summary>

    Only if penetration and residual behaviour have been confirmed for that vessel. Fenggu supports VHP culture-vessel penetration confirmation as part of validation.<\/p><\/details>

    How long is the changeover?<\/summary>

    It depends on chamber volume, load and the residual target. It is fixed during cycle development \u2014 measure it early because it limits batch throughput.<\/p><\/details><\/div>\n<\/div><\/section>\n