;Superheated Hot Water Sterilizer - Manufacturing Companies in India Superheated Hot Water Sterilizer - Manufacturing Companies in India

Manufacturing Companies in India

PharmaChem Cosmetic Industries,

a leading Superheated Hot Water Sterilizer Manufacturer in Mumbai, has developed an advanced and reliable Superheated Hot Water Sterilizer designed to meet the stringent sterilization requirements of the pharmaceutical and cosmetic industries. This innovative system uses superheated water under controlled high pressure to effectively sterilize vials, ampoules, bottles, and PE containers. By overcoming the limitations of conventional steam sterilization, it ensures uniform heat transfer, precise temperature control, and enhanced process reliability while fully complying with the latest international pharmaceutical regulations and GMP standards.

Also known as Superheated Water Spray Sterilizers, the Superheated Hot Water Sterilizer uses superheated water as the sterilizing medium, maintaining a controlled temperature–pressure relationship throughout the cycle. This ensures uniform sterilization without container deformation or breakage, making it ideal for heat-sensitive products and sealed containers. Its robust construction, automated controls, and energy-efficient operation deliver reliable, repeatable, and compliant sterilization for pharmaceutical applications.

In the Superheated Hot Water Sterilizer, products are carefully loaded onto specially designed stainless steel carriages that ensure safe handling and optimal exposure during the sterilization cycle. Once loaded, the Superheated Hot Water Sterilizer operates by circulating deionized or purified water, which is uniformly sprayed over the entire product load through a high-efficiency spray manifold. This uniform water distribution guarantees consistent heat transfer to all containers, eliminates cold spots, and ensures effective and repeatable sterilization throughout the chamber.

The process water is continuously drawn by a sanitary centrifugal pump and passed through a high-performance heat exchanger, where it is indirectly heated using externally supplied steam. This controlled heating arrangement allows the temperature to rise gradually, minimizing thermal shock to both the product and the container. Heating rates can be adjusted based on product sensitivity, container material, and process requirements, making the Superheated Hot Water Sterilizer suitable for a wide range of pharmaceutical and cosmetic applications.

A critical feature of this system is its precise pressure compensation mechanism. Throughout the sterilization cycle, chamber pressure is accurately regulated to closely match the internal container pressure, preventing deformation, collapse, or bursting of sealed or flexible containers. Once the validated sterilization temperature is reached, the holding phase begins, during which temperature and pressure are automatically maintained for the required duration to ensure complete microbial inactivation.

After completion of the sterilization hold time, controlled cooling is initiated by stopping the steam supply and introducing cooling water. This allows the product to cool down gradually to a safe unloading temperature. At the end of the cycle, the load is removed, and the process water can be reused if required, reducing water consumption and operating costs. With its efficient design, automation, and reliable performance, the Superheated Hot Water Sterilizer offers a safe, economical, and compliant solution for modern pharmaceutical manufacturing facilities.

Superheated Hot Water Sterilizer
  • GMP-Compliant Construction:
    The sterilizer chamber, piping, and product-contact parts are manufactured from high-grade SS 316 / SS 316L, ensuring corrosion resistance, ease of cleaning, and full compliance with cGMP and pharmaceutical regulatory standards.

  • Uniform Spray Distribution System:
    A specially engineered spray manifold and nozzle arrangement ensures complete and uniform coverage of the product load, eliminating cold spots and ensuring consistent sterilization across all containers.

  • Energy-Efficient Operation:
    The optimized heat exchanger design and recirculation system reduce steam and water consumption, resulting in lower operating costs and improved overall energy efficiency.

  • Validated Sterilization Cycles:
    Designed to support DQ, IQ, OQ, and PQ documentation, the system ensures easy validation and repeatability, making it suitable for regulated pharmaceutical production environments.

  • Automated Cycle Control:
    Fully automated operation minimizes human intervention and errors. Recipe-based cycle control allows quick selection and repeatable execution of validated sterilization programs.

  • Advanced Safety Interlocks:
    Equipped with safety interlocks, alarms, pressure relief valves, and emergency shutdown features to ensure safe operation and operator protection at all stages of the process.

  • Data Recording & Traceability:
    Integrated batch recording, temperature–pressure trending, and optional 21 CFR Part 11–compliant data logging ensure complete traceability and audit readiness.

  • Gentle Cooling System:
    Controlled cooling using recirculated water prevents sudden temperature drops, protecting container integrity and product quality.

  • Flexible Load Handling:
    Custom-designed loading trolleys and racks accommodate different container sizes and formats, offering high operational flexibility

  • Low Maintenance Design:
    The closed-loop system minimizes contamination, scaling, and water loss, reducing maintenance requirements and extending equipment life.