INNOVE HPB Passboxes

Innovate HPB

PRINCIPLE

VHP technology refers to low-temperature sterilization technology that vaporizes liquid hydrogen peroxide into hydrogen peroxide vapor and uses the vaporized hydrogen peroxide to sterilize the surface of objects.

VHP has broad-spectrum bactericidal properties and can effectively kill all types of microorganisms such as bacteria, fungi, molds, viruses, and bacterial spores. Currently, it has been found that the most difficult microorganism to kill with VHP is thermophilic fat spores, so the biological indicator used for VHP sterilization validation is thermophilic fat spores.

VHP sterilization is non-toxic and residue free, and vaporized hydrogen peroxide can quickly kill microorganisms during the sterilization process. After sterilization, it can quickly degrade into H ² O and O ², non-toxic and residue free, and the residual concentration of hydrogen peroxide can be detected.

The sterilization effect of VHP can be verified, and a normal validation cycle includes parameter development, VHP distribution research, biological challenge testing, and exhaust degradation research. The Innovate-HPB vaporized hydrogen peroxide equipment has a complete GMP validation document system.

VHP sterilization has good compatibility, and the Innovate-HPB series vaporized hydrogen peroxide sterilizer adopts a unique saturation control method to ensure that peroxide does not liquefy or condense during the entire sterilization process, resulting in better material compatibility.

Structure/Structure

PRODUCT SPECIFICATIONS

STERILIZATION PROCESS

Preparation: In the preparation phase, the temperature and humidity conditions of the chamber are automatically adjusted before the equipment is started, and the heating plate is heated synchronously to ensure that the equipment meets the sterilization prerequisites.

Balance: Activate sterilization conditions, and the equipment performs self balancing of VHP concentration and saturation to achieve sterilization conditions.

Sterilization: Start sterilization, accumulate to the sterilization set value, until sterilization is completed.

Degradation: After sterilization, the equipment enters the exhaust degradation stage, where VHP is discharged and degraded until the program ends.

Standard Procedure/PROCESS STANDARD-LOGA Procedure: Using the process control method of D value and sterilization LOG value of inactivated microorganisms, the sterilization process is stably adjusted to achieve the set sterilization conditions, generally set as the 6LOG procedure.

- LOGB program: Using the process control method of killing microbial D value and sterilization LOG value, the sterilization process is stably adjusted to achieve the set sterilization conditions, generally set as a 12LOG excessive killing program.

- Concentration program: The sterilization process adopts concentration and time control methods, and sets the program according to the sterilization concentration and time conditions developed based on parameters to achieve the set sterilization conditions.

Self purification program: The internal self-cleaning of the chamber is achieved through the filtration of an efficient filter, allowing for transfer without the need for sterilization, replacing some of the functions of the self-cleaning transfer window.

INTRODUCTION TO COMMON MATERIALS

VERIFICATION CODE

A validation document system that meets the requirements of FDA, WHO, EUGMP, and cGMP.

We can provide validation files and services from URS, FS, DQ, FAT, SAT, IQ, OQ, and PQ.

STANDARD CONFIGURATION

Optional

- ASME BPE process piping: The process piping is made of 316L stainless steel material, and welding logs and reports that comply with ASME BPE are provided.

Audit Trail: Using Siemens Audit Trail module and authorization to achieve FDA compliant audit trail requirements.

Electronic Signature: Compliant with 21CFR Part 11 electronic signature function, generally required on FDA standard projects.

Biological sealing: meets the biological sealing requirements of BSL-3 or BSL-4 and is selected for biosafety projects.

GMP validation (FAT, SAT, DQ, IO/PQ): Validation documents and services that meet GMP requirements can be purchased according to demand.

Spare parts kit: Components and consumables used for daily or regular maintenance of equipment, including inflatable sealing rings, silicone tubes, VHP concentration probes, H14 high-efficiency filters, etc.

Loading vehicle: made of 304 stainless steel material, used for the transportation of cavity loading brackets, easy to use.

VHP low concentration probe: installed on the exhaust duct, used to detect the VHP concentration at the end of sterilization.

Clean side operation screen: enables double-sided operation and observation of the equipment for ease of use.

TCP/IP network port: used for electronic data transmission and connection between devices and SCADA systems.

Venturi nozzle: assists in the distribution of hydrogen peroxide inside the VHP transfer window of the large cavity to achieve better distribution effect.