Sterilization

sterilization
Most modern technique is utilized for the removal or destruction of all microorganisms. The proper usage of the term sterile and sterilization signifies the absence of all microorganisms. In the process of sterilization product remains free of organism regardless of the duration or condition of storage.

Alshifa has deployed two methods of sterilization.

  • ETHYLENE Oxide Gas sterilization using full automated cycle for in-chamber precondition and sterilization for both 8 pallet and 12 pallet sterilizers. Sterilizer are validated ISO 11135-1:2007, Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Product release is on based biological indicator and EO indicator are used one each secondary and master cartons to distinguish between sterile and unsterile products. EO Gas changes EO indicators change from purple to green after the product passed thru sterilization process.
  • GAMMA Radiation Sterilization 25-kGy dose is generally accepted as the minimum required dose to sterilize medical products. In some cases The Bio-burden-Based approach is based on the ISO/AMMI Guideline, in which the highest SAL 10-6 is achieved by combining the knowledge of microbial quality of a product, raw materials and the manufacturing environment to validate the acceptable minimum dose rate. It often results in the determination of an acceptable dose to sterilize/sanitize the product. Gamma Radiation Sterilization leaves no residues, and imparts no radioactivity to the product. This makes it one of the safest sterilization technologies of today and in the future.

Sterilization Dept., provides contract sterilization services to the medical industry for sterilization of various medical finished products, like Plastic Disposable Syringes, Surgical Latex Gloves, Anti-Septic & Paraffin Dressings, Sutures) and other Medical Items-Silicon Suction Bulbs. Eye Ointments, etc. Treating all raw materials for the pharmaceuticals and cosmetics industry will lower the microbiological bio-burden of the Raw materials, which in turn will benefit in lowering their processing total cost.


Maintenance

ALSHIFA has its own Maintenance Department to take care of all kinds of electronic and mechanical preventative and major maintenance. The Department is supported by a well equipped workshop and well trained technicians and engineers to handle urgent repairs of sophisticated machines and components, as inventory of spares minimizes down time in case of breakdowns.