Auto Clave

Pharmachem Cosmetics Industries, as a leading AutoClave Manufacturers in Mumbai, produces PCI Superheated Water sterilizers capable of conducting counter-pressure sterilization for large-volume parenteral solutions using an advanced superheated water spray system. Steam sterilizers are also recognized by the name autoclaves.

In compliance with cGMP and FDA standards for LVP products, PCI autoclaves are suitable for treating loads in containers that may be deformed due to the difference in pressure between the chamber and the container itself. Autoclave Suppliers in Maharashtra, supply liable products for separation or for accelerating thermal transition phases, the whole load can be rotated during the entire sterilization process. There is minimum involvement of manual labor, simplified maintenance, and utilizing modular construction techniques to provide flexible installation options.

An autoclave is a device that offering by Autoclave Manufacturers and Suppliers in India, that employs steam under pressure to eliminate harmful bacteria, viruses, fungi, and spores from items enclosed within a pressurized vessel. These items undergo heating to achieve an optimal sterilization temperature for a specified duration. The steam's moisture facilitates effective heat transfer, disrupting the protein structure of bacteria and spores. Due to these attributes, it stands out as a prominent exporter in the industry.

Auto Clave

Design & Technical Features:-

  • AISI 316Ti (AISI 316L upon request) stainless steel chamber, which can have a circular or square part, according to the customer’s or process’ need.
  • The Chamber array is from 200 to 6.800 liters, but the filling capacity is fully customizable, conferring to the customer’s need.
  • The chamber's internal surface is electro-refined and complies with rigorous pharmaceutical standards, with a roughness Ra <0,4 mm.
  • Can feature one or two doors, employing either vertical or hinged opening systems to optimize space utilization effectively.
  • 4 RTD PT100 temperature probes per slot to monitor chamber and product temperature.

Compliant to:-

  • ISO Standard: 9001:2015, 13485:2016
  • European advice: 2014/68/EU – Pressure Equipment Device (PED), 2006/42/EC – Safety of machinery, 2014/30/EU – Electromagnetic compatibility, 2014/35/EU – Low-voltage device, 2007/47/EC – Medical device
  • European standards are: EN ISO 12100, EN ISO 13857, EN ISO 13849-1 EN 55001, EN 61000-4-2, EN 61000-4-4, EN 61000-6-2, EN 61000-6-4, EN 60204-1
  • ASME: Stamp R, Stamp S, Stamp U
  • Chinese standard: SELO
  • Swiss standard: SR 930.114
  • FDA
  • GMP

Key Benefits:-

  • Process optimization: The process is quicker than the air-steam sterilization process. PCI is also a perfect sterilizer for <105 °C processing. Wet loads can be overcome using an automated drying extension with the installation of exact drying solutions downstream of the sterilization chamber.
  • Easy validation & integration: Thema4 procedure controller is pre-validated according to GAMP5 and in obedience to 21 CFR Part 11, thus resulting in the least qualification time and minimizing project risks. Open system architecture that can be joined with the SCADA system and other Fedegari machines.
  • Highest productivity: Fedegari R&D laboratory is available to grow the best treatment result for your specific needs. We run tests with different loads and desires.