Hydrogen Peroxide Vapor
Liquid hydrogen peroxide without stabilizers. Concentration: 35%
It is not combined with other chemicals.
All equipment present in clean rooms is suitable for VHP.
They should only be removed:
pH meter or equipment with a visible probe that may suffer deterioration due to oxidation.
Exposed ferrous material must be protected or it will suffer from rust and discoloration.
Organic material can undergo oxidation: remove any solution or compound that
can rust.
Untreated wood. If exposed, it may swell by absorbing
humidity.
It depends on the volume size of the room and the amount of equipment present in the room.
same. In addition, it will depend on the temperature and humidity conditions of the
ambient.
By increasing the percentage of humidity in the environment, the procedure is prolonged in
duration because an increase in humidity competes with the peroxide levels of
hydrogen in the environment, preventing it from reaching the necessary concentration to reach
sterilization. In addition, it could generate deposits of hydrogen peroxide in the
concentration liquid much greater than 35%.
The process only leaves water and oxygen as waste, by-products of the
hydrogen peroxide catalysis reaction.
Yes, physical cleaning is important to remove biofilms.
The basic requirements are that the room is:
● Clean and dry
● Seal the returns and/or ducts to achieve the hermeticity of the room
No, the room is sterile and ready to use.
No, the room must be free of staff.
The time will depend on the size of the room. After a period of time has elapsed
room ventilation, you can re-enter the room. To speed up the process of
re-entry, a catalyst or fans/air conditioners may be used.
The service can be validated using biological indicators composed of 1,000,000
spores of a thermostable microorganism and resistance. Once the
procedure, they are cultured and the results are observed.
Chemical indicators are also used to validate the presence of hydrogen peroxide gas.
hydrogen in the enclosure.
No, it has multiple applications. From Class I to Class IV labs, grade rooms
A B C or D, equipment (fillers, packaging machines, bioreactors, isolators), cabins of
biosafety (cabin sterilization or change of filters). Can be used for
sterilize products that will be transferred from grade B -> A rooms, among others
Applications
Air Particulate Monitoring
We recently implemented the traceability download from the cloud in Google drive.
Along with the calibration certificate, a sheet with a QR code is attached.
By scanning said QR code, you will be redirected to the page from where you can download the traceability.
You do not need to log in with an account to download the files, just have access to the link, which is private. It is only shared with customers.
If you do not have the QR sheet, you can request it by email to soporte@opyr.com.ar
clarifying the serial number of the calibrated equipment or upload a ticket on our website https://opyr.com.ar/helpdesk and you will be sent the link to access the downloads.
Ideally, the probe would be positioned in the middle of the flow or at a higher point in it. It is recommended to carry out test measurements during an operation, with the probe positioned at different nearby points, and thus observe the variation in the counts obtained in each of them.
They could send us photos with the equipment plan and request a technical visit for better advice.
Before implementing hose lengths greater than a meter and involving bends, the possible loss of particles must be evaluated and whether this will affect the sampling to be carried out. We invite you to read the following technical note:
https://drive.google.com/file/d/1UF2e1xAoLdRZ0xiYZL0gdICBN37E5nFr/view?usp=sharing
The configuration of the alarm levels depends on the sampling volume. You can get all the details in the following technical note:
https://drive.google.com/file/d/1MfjKAQtR4BxJyvwAK1BV-JpE4v70A_D9/view?usp=sharing
It is recommended to replace the batteries after five years of use. Depending on the use of it and the maintenance carried out, its useful life may be exhausted after a few years of use. For more information, we invite you to read the following technical note:
https://drive.google.com/file/d/15sXsMqj06SfQbGhGeKWK99OmYjUk_xwl/view?usp=sharing
We invite you to watch the following video with the steps to follow:
https://drive.google.com/file/d/1CbetAyI5Arg9z5-GZ4E-O44I7v--WkRU/view
Important: To change the activation status of a computer, the computer must be turned on/powered on and connected to the network.
For more information, read the following instructions that include other videos:
https://drive.google.com/file/d/1654kGcfUnZOgYdWDEuo5ntBh8QGdt8kk/view?usp=sharing
It is possible as long as a domain is installed. In this way the software can ensure compliance with 21 CFR. DataPro3 regulates access with windows users, so it is necessary for the client to have a domain administrator user to be able to enable users in the software. For more information and advice, contact us by phone or e-mail.
Important: the equipment must be turned on/energized and connected to the network.
The equipment may not be sampling/measuring:
Every time you turn on a device from the ON/OFF key on its rear panel, observe the activation status of said device in the main DataPro3 tab: “Overview”.
If the equipment was activated (Active) from the “Control” tab and OK is found in “Overview”, then the equipment is sampling, and therefore the measurements are saved in the database.
Otherwise, if it is deactivated (Standby) from the “Control” tab and it is OFF in “Overview”, then the unit is NOT sampling. The equipment is not collecting data, even though it is powered and connected to the network.
To see other alarm states in "Overview", we invite you to read the following instructions:https://drive.google.com/file/d/15nb8TQe5NclXdvIi-K56C1wryVj9cDyo/view?usp=sharing
The firmware update is carried out on a discounted basis in our offices. Before the update, the current configuration and data are backed up. The measurements made will be saved in a file.csv. After the update, a report and an annex with the history of firmware revisions are issued.
If the equipment is operational and has no faults, the calibration is done in an average of 2 (two) hours in our offices. The service must be previously coordinated and give notice of the shipment of the equipment.
Priority is given to teams whose shifts were previously scheduled and submitted the corresponding purchase order to Liliana administracion@opyr.com.ar