Validation Services

Whether the ESTERI product operates to specifications and has the required performance
or a validation service that verifies and records whether it is maintained
Here is the information.

Validation Services (Table of Contents)
  1. What is validation
  2. GMP-based management
  3. Measurement instrument management based on HACCP, etc
  4. About ESTERI's validation services
  5. Validation points
  6. Contact Us

What is validation

Validation is the effort to ensure and record that installed equipment and work processes consistently achieve the expected performance and results.
It is often performed as part of equipment maintenance in the pharmaceutical, health food, and supplement industries.

The autoclave verifies that the equipment to the specifications required for installation is properly installed and that the desired operating results can be obtained after installation Introduction validation)
It is also even more important to ensure that this validity is maintained regularly, not just at the time of purchase.( Regular Validation)

Validation is often required by a management rule called GMP. The following section will explain GMP.

GMP-based management

GMP stands for Good Manufacturing Practice, which in Japanese is "a standard for manufacturing control and quality control of pharmaceuticals, quasi-drugs, etc."
As mentioned above, it is widely used not only in the pharmaceutical industry but also in the health food and supplement industries.
In Japan, management is primarily based on the Ministry of Health, Labour and Welfare's GMP Ministerial Ordinance (J-GMP).
Some organizations also operate the US FDA's cGMP and the European EU GMP together, depending on the company's backbone, export partner country, and trading area.
(These three major GMPs are called trilateral GMPs.)

Reference link: Ministry of Health, Labour and Welfare Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Pharmaceuticals and Quasi-drugs (GMP Ministerial Ordinance)

Since the establishment of the Trilateral GMP, it has been increasingly problematic that GMPs operated in different regions of each country have differences in management levels and auditing standards.
Therefore, in 2000, the PIC/S GMP, a unified international standard, was established by an organization called PIC/S, which is comprised of member auditing authorities from each country.
Currently, it is no exaggeration to say that adoption is an essential GMP management standard for pharmaceutical companies with a global presence.

In all GMP management regulations, product quality is not relied solely on final inspection, but rather on the acceptance of raw materials, manufacturing processes, equipment, work procedures, record keeping, etc The basic management mechanism is based on three principles: "minimizing human error," "preventing contamination and quality degradation," and "designing systems that guarantee high quality." The regulations stipulate that equipment used in manufacturing and testing must be objectively recorded 『that it is in a state of proper use for its intended use』, and one of these efforts is validation.

Measurement instrument management based on HACCP, etc

In the food industry, there are HACCP and FSSC22000, which are management regulations equivalent to GMPs used in the pharmaceutical/health food industry.
Both initiatives aim to prevent foreign matter contamination and microbial contamination by predictive analysis. In particular, autoclaves used for sterilization require strict control over temperature and time, and the keeping of records.

In particular, FSSC22000 requires detailed control not only for CCP (Critical Control Point) equipment required by HACCP, but also for OPRP (Operational Prerequisite Program) equipment, as well as all monitoring equipment, including general hygiene and environmental measurements. However, if the thermometer or sensor that forms the basis of the record cannot measure correctly, the reliability of the management record itself will decrease.

『Accurate instruments are necessary to ensure that the device operates accurately and that the device's condition is accurately confirmed.』 This requires periodic calibration of the temperature and pressure sensors installed in the device to verify the accuracy of the measuring instruments. ( Unlike GMP, this often does not involve checking the operational performance eligibility or operational performance eligibility of the device itself.)

About ESTERI's validation services

The validation services we offer are as follows: We will ask you about your preferences and provide you with the most appropriate calibration work, customized for you.

Delivery Validation

After the device is installed, validation such as IQ/OQ is performed.

Checking eligibility at time of installation (IQ)
Verify that the device is properly installed and in a state where it can be used normally.
Instrument Calibration (Instrument CAL)
Check that measuring instruments such as temperature sensors, pressure sensors, and main control devices maintain the specified accuracy.
Operational Qualification (OQ)
Operate the device without load and check that the set temperature, pressure, etc. are controlled normally.
Regular Validation

We will verify that the equipment in use maintains its performance at the time of delivery.

Instrument Calibration (Instrument CAL)
Check that measuring instruments such as temperature sensors, pressure sensors, and main control devices maintain the specified accuracy.
Operational Qualification (OQ)
Operate the device without load and check that the set temperature, pressure, etc. are controlled normally.
HACCP/FSSC 22000 support

Checking the accuracy of measuring instruments ensures the operation of food safety management.

Instrument Calibration (Instrument CAL)
Check that measuring instruments such as temperature sensors, pressure sensors, and main control devices maintain the specified accuracy.

Validation points

There are factors that are affected, such as temperature, time, and pressure.
Other additions may be made depending on the individually requested use, but the following are general examples.

In the case of an autoclave
Temperature distribution accuracy
Whether the default temperature distribution accuracy is met at each measurement point within the can during operation.
Sterilization timer accuracy
The set sterilization timer time and the actual timer operating time are consistent, and the default accuracy is met.
Pressure control state
The temperature is controlled within a reasonable pressure range for a preset setting.
In the case of a dry heat sterilizer
Temperature distribution accuracy
Whether the default temperature distribution accuracy is met at each measurement point in the tank during operation.
Sterilization timer accuracy
The set sterilization timer time and the actual timer operating time are consistent, and the default accuracy is met.
In the case of an incubator
Temperature distribution accuracy
Whether the default temperature distribution accuracy is met at each measurement point in the tank during operation.
Common items
Instrument calibration
Before verification, which requires operation, it is necessary to verify that the measurement accuracy of the temperature sensors, pressure sensors, pressure gauges, etc. used in the device meets the specified range ※)
※In some cases, only instrument calibration is performed, not the need for verification that requires driving

Contact Us

For any validation requests or other inquiries, please contact us using the contact form at the button below.

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