Systems for the Pharmaceutical Manufacturing Field
Currently, there is a strong demand for the introduction of development, manufacturing and control systems in accordance with GxP at pharmaceutical manufacturing and development sites. And, in pharmaceutical manufacturing, water quality control in line with the GxP guidelines is also required for water used as raw materials and rinsing water.
The TOC-V Series conforms not only with USP (United States Pharmacopeia) and JP (Japanese Pharmacopeia) but also with other world standards (EPA, ASTM, JIS, ISO, etc.), and demonstrates its outstanding performance in TOC control and cleaning validation of pharmaceutical water.
When linked with the TOC-Control V
PC control software for TOC-V and the CLASS-Agent
network-compatible analytical data management tool, the PC-control type TOC-V provides powerful support for FDA as an outstanding data control system compatible with "FDA 21 CFR Part 11."
Supporting the Control of Impurities in Pharmaceutical Water Compliant with Pharmacopeia in Each Country
Organic impurities in pharmaceutical water are controlled by using TOC in the Pharmacopeia in the United States and the EU.
TOC is also used as the general test method in Japanese Pharmacopeia. The TOC-V series is compliant with Pharmacopeia in these countries.
The following is stipulated in general test methods according to the Japanese Pharmacopeia:
- The TOC analyzer must be able to measure TOC at a concentration of 0.05 mg/L.
- Calibration must be able to be performed using potassium hydrogen phthalate.
- The collection ratio of sodium dodecylbenzene sulphonate solution with a TOC concentration of 0.5 mg/L must be 90% or more.
Furthermore, according to the Japanese Pharmacopeia, the following pharmaceutical water must be controlled by TOC:
- Of water for injection, water that is purified by ultra-filtration methods for adjustment of injections
Moreover, according to reference information "Water Quality Control of Pharmaceutical Water," water control by TOC is recommended for pharmaceutical water, such as water for injection or purified water. Even for water used as raw water for manufacturing pharmaceuticals, the implementation of TOC measurement-based water quality control with appropriate criteria values established in each manufacturing facility is recommended.
Though TOC measurement as stipulated in the Water Supply Act is required for water, this act also requires that water containing suspended organic substances is measured in case suspended substances should by chance enter the tap water.
The TOC-VCPH/CSH, which uses the 680 °C combustion catalytic oxidation method, can completely oxidate and separate suspended substances that are potentially contained in water. It also has sufficient sensitivity at a detection limit of 4 µg/L for measuring pharmaceutical water, thus enabling ideal water quality control.
Revised Draft for the Japanese Pharmacopeia Relating to Pharmaceutical Water (for the 16th Edition, Disclosed April, 2009)
A revised draft for greatly re-organizing classical chemical items for testing purity has been set forth to comply with EP and USP standards. Namely, a change has been made such that organic impurities in purified water and water for injection in bulk are now to be controlled by TOC, and organic impurities in bottled purified water and water for injection are still controlled by the currently-used "potassium permanganate reduced substance."
Accurate and Speedy Cleaning Validation by Swab Method
Solid Sample Combustion Unit SSM-5000A
In pharmaceutical manufacturing facilities, "residue evaluation testing" must be performed to scientifically prove that pre-product or detergent residue, external contaminants, etc. are at pre-determined allowable limit values or lower.
Key points in residue evaluation testing are analysis method, allowable limit values and sampling method.
Of the sampling methods, the swab method is highly appraised and recommended by the FDA and Japan's Ministry of Health, Labor and Welfare. By this method, a swab is used to physically wipe a fixed area on the surface of equipment to take up attached residue for analysis, allowing attached insoluble residues to be physically wiped off and sampled. As a result, measurement can be performed quickly and even more accurate evaluations can be made.
When used in combination with the SSM-5000A Solid Sample Combustion Unit
, the TOC-V series instrument can directly measure swabs without the need to extract residue from them and transfer it to water for measurement, thus rapidly speeding up the measurement process and ensuring greater accuracy.
Swap Method in GMP-Compliant Cleaning Validation
Equipment Validation Supported
The GLP/GMP guidelines also require validation of analytical instruments.
For the TOC-V series, validation is checked at installation, and "IQ" documentation to certify that installation has been conducted properly and "OQ" documentation that outlines procedures for periodic checking of the system are provided to support validation.
Part11-Compliant Electronic Signatures and Electronic Records Supported
Also, by linking with the TOC-Control V
PC control software for TOC-V and the CLASS-Agent network-compatible data management tool for analytical instruments, the PC-control type TOC-V ensures data reliability as an outstanding data control system compatible with "FDA 21 CFR Part 11."
For Research Use Only. Not for use in diagnostic procedures.
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