Pharmaceutical Industry

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Pharmaceutical Industry

Ferlo designs and manufactures autoclaves for the pharmaceutical industry meeting the highest international standards of quality for this market.

The construction and design of Ferlo “STERIFER” autoclaves is done following the standards of good manufacturing practices, according to GMP and FDA (Food and Drugs Administration), as well as complying with the applicable national and international standards to date. (IRAM, DNI, ISO, EN).

 

Characteristics

  • Optional door for loading and unloading areas which are suitable for sterile areas and have security software that prevents the simultaneous opening of both doors at the same time.
  • Pressure system supported by shower-heated waterfor the sterilization of liquids in airtight containers.
  • Suitable for use in steam central lines.
  • Fully Programmable processes.
  • Touch Screen control panel, PLC  and programming with multichannel recorder.
  • Terminal with printer.
  • Body built entirely of stainless steel AISI 316.
  • Trays and carts designed to allow automation of loading and unloading.
  • The fronts and outdoor coverage built of stainless steel AISI 304 with orbital polishing.
  • The Autoclave is mounted on a support base for accessible movement, leveling and anchoring.

injectables, liquid vials, serum, plasma vials or bags.

Validations

The terms qualification and validation can be used interchangeably, although we generally refer to qualification when it comes to computers and validation processes or methods.

  • Technical Specifications and Design (DS)
  • Functional Specifications (FS)
  • Commissioner
  • Control Change (CC)
  • Acceptance Criteria (AC)
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Provision qualification (PQ)
  • Factory Acceptance Test (FAT)
  • Qualification Report
  • Worst case
  • Piping and Instruments Diagrams (P & ID)
  • Plan Qualification, Validation Master (VMP) Plan
  • Qualification Protocol
  • Retraining
  • Site Acceptance Test (SAT)
  • Validation

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