Validation Services Quote Request


Thank you for your interest in our Validation Services. To receive a quote for services, please complete the form below. If you have requests for multiple products, you will need to complete a quote request form for each one. To facilitate the process, we recommend logging into your account above and forms will pre-fill with your contact details.
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Important Notice: If you are accustomed to our processes or otherwise comfortable with online submissions, please complete the Quote Request Form in one session.
However, if you are new to this process or prefer an offline approach, kindly contact us to request the Excel version.

Should you have any questions, please click on contact us and a team member will contact you directly.
Fields indicated by a * are mandatory.

Contact Information






Fill in your company name as you would like to appear in your protocols/reports

Street number & name




General Information


Select all that applies. This information is important in order to apply the appropriate regulatory expectations to your validation services.”

Complete this form in English if protocols/reports are required to be in English

Specify the deadline for regulatory submission date (MM/DD/YYYY) if you have any. We may charge additional fees for any urgencies

If none applies choose 'Other'

Product Information


Specify the name of the product you would like us to validate. This should be the name you would like to appear on protocols/reports






If you have any product limitation, specify in ml or liters the maximum volume of product you will be able to provide for the tests





Indicate all your ingredients from your product formulation including the dilutent. Add or remove lines as appropriate to describe your full product composition


Add another ingredient

Device to Validate


Please note that depending on this entry, additional fields will appear in order to describe the process conditions for each of the different types

Enter the catalog number of the device you want to validate. If you are using a Mobius assembly and you only want to validate the filter then report only the filter catalog number and not the Mobius assembly number

Choose your Validation Services






Fill in the hours for the total contact time product/filter from your manufacturing batch. This includes dynamic filtration time & stoppage time for ONE batch

If you have a specific intermittent pattern please indicate the number of filtration cycles you would like us to simulate

Minimum & maximum of your manufacturing batch


Precise number of batches processed on the same filter

Do not take into account the flush fluids




If you use 2 sterilization modes then describe for each one (example: autoclave 121°C SIP 135°C)

If you use 2 sterilization modes then describe for each one (example: autoclave 20 minutes SIP 30 minutes)

Indicate the maximum number of sterilization cycles you would apply to the filter for ONE batch. If you use 2 sterilization modes then describe for each one (example: autoclave 2 cycles SIP 1 cycle)

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage



Indicate the temperature range when you perform the integrity test of your filter in production. If the range is wider than 8°C, then two integrity tests will be quoted


It is a compatibility report based on bibliographic research (qualification documents & compatibility charts & literature). No test protocol is provided







Fill in the hours for the total contact time product/filter from your manufacturing batch. This includes dynamic filtration time & stoppage time for ONE batch

If you have a specific intermittent pattern please indicate the number of filtration cycles you would like us to simulate

Minimum & maximum of your manufacturing batch


Precise number of batches processed on the same filter

Do not take into account the flush fluids




If you use 2 sterilization modes then describe for each one (example: autoclave 121°C SIP 135°C)

If you use 2 sterilization modes then describe for each one (example: autoclave 20 minutes SIP 30 minutes)

Indicate the maximum number of sterilization cycles you would apply to the filter for ONE batch. If you use 2 sterilization modes then describe for each one (example: autoclave 2 cycles SIP 1 cycle)

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage



Indicate the temperature range when you perform the integrity test of your filter in production. If the range is wider than 8°C, then two integrity tests will be quoted


It is a compatibility report based on bibliographic research (qualification documents & compatibility charts & literature). No test protocol is provided






Fill in the hours for the total contact time product/filter from your manufacturing batch. This includes dynamic filtration time & stoppage time for ONE batch

If you have a specific intermittent pattern please indicate the number of filtration cycles you would like us to simulate

Minimum & maximum of your manufacturing batch


Precise number of batches processed on the same filter

Do not take into account the flush fluids




If you use 2 sterilization modes then describe for each one (example: autoclave 121°C SIP 135°C)

If you use 2 sterilization modes then describe for each one (example: autoclave 20 minutes SIP 30 minutes)

Indicate the maximum number of sterilization cycles you would apply to the filter for ONE batch. If you use 2 sterilization modes then describe for each one (example: autoclave 2 cycles SIP 1 cycle)

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage



Indicate the temperature range when you perform the integrity test of your filter in production. If the range is wider than 8°C, then two integrity tests will be quoted


It is a compatibility report based on bibliographic research (qualification documents & compatibility charts & literature). No test protocol is provided







Fill in the hours for the total contact time product/filter from your manufacturing batch. This includes dynamic filtration time & stoppage time for ONE batch

If you have a specific intermittent pattern please indicate the number of filtration cycles you would like us to simulate

Minimum & maximum of your manufacturing batch


Precise number of batches processed on the same filter

Do not take into account the flush fluids




If you use 2 sterilization modes then describe for each one (example: autoclave 121°C SIP 135°C)

If you use 2 sterilization modes then describe for each one (example: autoclave 20 minutes SIP 30 minutes)

Indicate the maximum number of sterilization cycles you would apply to the filter for ONE batch. If you use 2 sterilization modes then describe for each one (example: autoclave 2 cycles SIP 1 cycle)

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage

This question will help to assess if there is an increased potential risk to the patient safety evaluation using worst case extractables and if a mitigation plan is needed at the quote stage



Indicate the temperature range when you perform the integrity test of your filter in production. If the range is wider than 8°C, then two integrity tests will be quoted


It is a compatibility report based on bibliographic research (qualification documents & compatibility charts & literature). No test protocol is provided



*Depending on your process details, the Advanced level may be required. If this is the case, our team will contact you to discuss the details.




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