Dear Eng.Kawther Abudayyeh

A medical device cleaning validation requires that the device is soiled with biological material in a manner that is clinically relevant. The soil will often depend on the type of device being tested, but typically is a mixtures of proteins, hemoglobin, and carbohydrates. Artificial Test Soil (ATS) is the most commonly used soil for medical device cleaning validations. Once soiled, the medical device will be cleaned according to the manufacturer’s instructions and any remaining soil will be extracted from the device.

Manual cleaning is the most frequently requested medical device cleaning validation method, but many hospitals and clinics use automated washer disinfectors for reprocessing reusable medical devices.  Therefore, ISO standards recommend that at least one automated cleaning method be validated. An automated cleaning validation is performed the same way as a manual cleaning validation except that the actual cleaning steps are performed by an automated washer/disinfector.

Medical device disinfection validations are performed differently depending on the level of disinfection required, high level disinfection, intermediate level disinfection or low level disinfection.  The level of disinfection is determined by the Spaulding Category of the device, critical, semi-critical or non-critical.  Critical medical devices come in contact with the blood stream and sterile parts of the body.  These devices must be sterilized.  Semi-critical devices come into contact with intact mucous membrane or non-intact skin but do not normally penetrate the blood barrier or sterile area of the patient.  Semi-critical devices should be sterilized but if the device can not withstand sterilization, high level disinfection may be used. Non-critical devices only contact intact skin.  Non-critical devices can be disinfected using intermediate or low level disinfection.

All disinfection validations require that the device be inoculated with bacteria and then exposed to the disinfectant.  Any remaining bacteria is extracted from the device and grown on plates in a manner similar to a bioburden test. High level disinfection requires a six log reduction of Mycobacteria.  A three log reduction of Mycobacteria and a six log reduction of four different vegetative organisms are required for intermediate level disinfection.  Low level disinfection requires only a six log reduction of four different vegetative organism.

Sincerely ...

From Ref.(https://pacificbiolabs.com/reusable-device-cleaning-disinfection-validations)

Ali A. Al-Allaq

Dear Mr Ali

thanks for your feedback

Kindly noted i ask about cleaning of non-sterile -topical medical device products production area

(solution ,gel cream )

and cosmetics