vanzari@infinitrade-romania.ro
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Infinitrade Romania – industrial equipment supplier in Romania

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    Equipment for the Pharmaceutical Industry

    GMP pharmaceutical production requires certified contact materials, usually 316L stainless steel, IQ/OQ qualification documentation and, for many applications, steam-in-place sterilisation (SIP) with no liquid stagnation zones. We quote peristaltic pumps for sterile transfer, diaphragm pumps, aseptic valves, sanitary heat exchangers and sensors for clean rooms. For a quote, send the process fluid, the flow rate, the type of sterilisation required and the specification.

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    Applications

    • Production of solid and liquid medicines
    • Biotechnology and biofermentation
    • Vaccine production
    • Pharmaceutical cosmetics
    • Clean room facilities

    Equipment we supply for pharmaceutical industry

    • Peristaltic pumpsSterile transfer without contamination, ideal for sensitive fluids
    • Diaphragm pumpsPTFE for aggressive fluids, optional ATEX certification
    • Aseptic valvesSterilisable in line (SIP), with GMP certifications
    • Sanitary heat exchangersFor batch processes, CIP/SIP compatible
    • Clean room sensorsDifferential pressure, temperature and humidity for clean room monitoring
    • Sterile pneumaticsCylinders and clean-design valves for pharmaceutical process automation

    Brands often requested

    • Grundfos BioBooster
    • Alfa Laval
    • GEA
    • Endress+Hauser
    • Festo

    Frequently asked questions

    What documentation do clean room and GMP production equipment require?

    To validate a GMP installation you need at minimum a material certificate (usually 316L stainless steel for product-contact parts), a CE declaration of conformity, a technical datasheet with tolerances and surface roughness, plus the manufacturer's IQ (Installation Qualification) and OQ (Operational Qualification) documentation. For equipment that can be sterilised in line (SIP), you also need data on resistance to the temperature and pressure of the sterilisation cycle. The documents are attached to the line's validation file and checked during GMP compliance audits (EudraLex Volume 4 or FDA 21 CFR 211).

    What is the difference between a peristaltic pump and a diaphragm pump for sterile transfer?

    A peristaltic pump moves the fluid through a flexible tube compressed by rollers, with the fluid never touching any mechanical component - ideal for sterile transfer of small to medium volumes, where cross-contamination must be eliminated completely, by changing only the tube between batches. A PTFE diaphragm pump resists aggressive or solvent-containing fluids and can run dry without damage, which makes it useful for transferring active substances or intermediate products. For areas with flammable solvents and ATEX certification, the pneumatic diaphragm pump is usually the simpler solution to certify under 2014/34/EU.

    What does an aseptic steam-in-place (SIP) valve mean?

    SIP (Sterilization In Place) means the valve can be sterilised with steam directly in the line, without dismantling, usually at temperatures above 121°C, held for the time defined by the validation process. The construction must be self-draining (no dead zones where residues or condensate can accumulate), and the seals must withstand repeated temperature cycles without losing elasticity or releasing particles. These valves come with a GMP certificate and, often, with test reports on seal life over repeated SIP cycles - ask the manufacturer for them before installation.

    What should a specification for equipment for a pharmaceutical line contain?

    A complete specification should state the contact material (usually 316L with a material certificate), the required surface roughness, the connection standard (Clamp, DIN 11864 for aseptic), the sterilisation requirement (SIP/CIP), the classification of the clean room (ISO 14644, usually class 5-8) in which the equipment will operate, and the expected qualification documentation (IQ/OQ, sometimes PQ). The more clearly you specify these criteria, the more comparable the quotes you receive, and the less likely you are to see large price differences caused by misunderstandings about the certification level required.

    How long does delivery of GMP-certified equipment take and what do we send for a quote?

    Lead times for GMP-certified pharmaceutical equipment are usually longer than for standard industrial equipment, because the manufacturer must issue the batch-specific qualification documentation. The lead time is 24–72 h when the item is available locally or at the supplier; made to order, usually 1–4 weeks; it may take longer depending on the brand and the specifications. For a quote, send us the process fluid, the required flow rate, the type of sterilisation required and whether you already have a specification with the reference standard. Our technical team checks the availability of the GMP documentation before the order is confirmed, so that there are no surprises at receipt.

    Other industries we supply

    Updated: 2026-11-12