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BIC LAB

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BIC Chemical Laboratory

The mission of ‘BIC Chemical’s Laboratory ‘ is to control the quality of all Raw materials, In-process products and finished products produced by BIC Chemical CO., Ltd. and BIC Corporation to meet the highest quality in compliance with International standards. We also provide Stability testing data for all BIC Chemical and BIC Corporation products, so our customer can be sure our products will maintain both quality and efficacy throughout their shelf life.

Quality Objectives
To perform a correctly analytical result under international standard to meet customers’ satisfaction
To complete all analytical results in a timely fashion customers’ specification and deliver schedule.
Efficiently and effectively manage resources for loss protection.
To educate and motivate our staff for a continuous improvement.

BIC CHEMICAL LAB

1.Quality System
BIC Chemical CO., LTD has been certified by many standards over the past few years; GMP/PICs, GMP Food, GMP Hazardous material (Non-food), HACCP, ISO 9001:2008, ISO 9001:2015 and FAMI-QS. We are confident in our ability to guarantee the efficacy of our products and provide authentic documentation. We established these quality systems to find the root cause of problems quickly and in an organized fashion to identify and prevent problems in advance, continuously improving our organization. BIC Chemical Laboratory achieved the international standard ‘ISO/IEC 17025:2005’ from Bureau of laboratory Quality standards, Department of medical and sciences and the Ministry of public health of Thailand. ISO/IEC 17025:2005 is the international standard that certifies laboratory’s management system meets set requirements for quality, administrative and technical operations. This certification confirms our compliance to currently accepted operating practices and recognizes our laboratory for this achievement.

From all above Quality standards, BIC Chemical can assure our products fulfill with quality and more convenient to export because confirmation testing is not necessary

BIC CHEMICAL LAB

2.Physical and Chemical Test
Our responsibilities are perform both physical and chemical test for raw materials, in-process products and finished products followed international pharmacopoeia; USP, BP, EP. Moreover we have the ability to test the amount of pharmaceuticals in feed for support BIC group’s feed products and customers. All testing method are already verified & validated. The process is to make confirmation though objective evidence that the specified requirements have been fulfilled, so the analytical results will be correct and able to be confirmed with others international laboratories. The up-to-date technology and quantity of calibrated analytical instruments will make sure that many tests can be run simultaneously and all analytical results are very reliable.

BIC CHEMICAL LAB

BIC CHEMICAL LAB

3.Mineral and Vitamin Test
BIC Chemical Laboratory emphasizes an effective analytical process to comply with the reference method from FAO JECFA and AOAC monograph for testing premix products, raw material of feed and feed. All steps of testing were performed by a specialist and high performance instruments such as ‘Microwave Plasma-Atomic Emission Spectrometer (MP-AES)’ that can detect a very small amount of minerals, vitamins and heavy metals with a high level of sensitivity and precision

BIC CHEMICAL LAB

Strength of MP-AES MP-AES is the next generation of proven microwave plasma - atomic emission spectrometry. The MP-AES has higher sensitivity, detection limits down to sub ppb levels, speed that goes beyond flame Atomic Absorption, and no combustible gases. Perform unattended analysis on a broader range of a samples while benefitting from the lowest cost of ownership with the revolutionary technology that runs on air.

BIC CHEMICAL LAB

4.Microbiology test
Microbiology laboratory is one part of BIC Chemical laboratory that focuses on performing testing to detect microorganisms in raw materials, pharmaceuticals, feed and water in the manufacturing process. All microbiology tests are performed under clean room conditions similar to the production area for injectable products where temperature, pressure, amount of particle and bacterial count for a more consistency can be controlled and prevent contamination among the tests are

Potency test for antibiotics –a measurement of power to kill or inhibit growth of certain microorganism
Microbial limit test – designed to perform the qualitative and quantitative estimation of specific viable microorganisms present in samples
Sterility test –a procedure to check the sterility of a sample by incubation of the sample with a sterile-culture media

BIC CHEMICAL LAB

BIC CHEMICAL LAB

BIC CHEMICAL LAB

BIC CHEMICAL LAB

Not only for supporting microbiology testing, but our microbiology laboratory also assists in the research and development of our fermented soybean from a beneficial microorganism and selecting the best strain for producing our probiotic products that improves growth, health, welfare and productivity of animals.

BIC CHEMICAL LAB

BIC CHEMICAL LAB

BIC CHEMICAL LAB

BIC CHEMICAL LAB

5.Disinfectant Quality control
The testing of our disinfectants are also performed under the same standards as pharmaceutical analysis. We test the microbial-killing activity for all disinfectant products with high performance technology such as HPLC, UV-Vis Spectrophotometry.

BIC CHEMICAL LAB

BIC CHEMICAL LAB

6.Stability testing The purpose of stability testing is to provide evidence on how the quality of pharmaceutical products varies over time under the influence of a variety of environmental factors such as temperature, and humidity. The results which are tested to comply WHO & ICH guidelines and ASEAN Stability guidelines helps support data for registration to set the shelf life of product. Stability testing uses 2 main conditions , long term testing and accelerating testing typically done as below

1. Long Term Testing means studying at high temperatures as prescribed. To accelerate Reaction to decomposition or chemical or physical change of drug or drug product by collection at room temperature 25 ± 2 0C Relative humidity 60 ± 5% RH or 30 ± 2 0C Relative humidity 75 ± 5% RH Label defining

2. Accelerated testing means the study of product stability. In order to confirm the quality of the product. During the discharge period, collect samples at 40 ± 2 0C relative humidity 75 ± 5% RH. Check storage period for 6 months.

Study Storage Condition Minimum time period covered by data at submission
Long-terma 25 ºC ± 2 ºC/40% RH ± 5% RH or 30 ºC ± 2 ºC/35% RH ± 5% RH 12 month
Intermediate 30 ºC, ± 2 ºC/65% RH ± 5% RH 6 month
Accelerated 40 ºC ± 2 ºC/not more than (NMT) 25% RH 6 month

BIC Chemical Laboratory layout BIC Chemical Laboratory layout is divided into 3 section

1. CHEMICAL TESTING IDENTIFICATION
ASSAY (%LA)
Active and Inactive Ingredient
Veterinary Pharmaceutical
Premixtures
Disinfectant and Detergent
Drugs in Feed
CHROMATOGRAPHIC PURITY / RELATED COMPOUNDS
UNIFORMITY OF DOSAGE UNITS
DISSOLUTION
RESIDUE ON IGNITION
WATER-SOLUBLE SUBSTANCES
ACIDITY AND ALKALINITY
2. PHYSICAL TESTING IDENTIFICATION
DENSITY / Specific gravity
pH
WATER
LOSS ON DRYING
MOISTURE CONTENT
EXTRACTABLE VOLUME / MINIMUM FILL
RANGE OF MEAN WEIGHT
DISINTEGRATION TIME
THICKNESS Thickness & Hardness
3. Retained and stability testing sample room
Temperature Control Room 25 ± 2 ºC, 60 ± 5 % RH
Temperature Control Room 30 ±2 ºC, 75 ± 5 % RH
Stability chamber 40 ± 2 ºC, 75 ± 5% RH

Continuous improvement under the international standard

BIC CHEMICAL CO., LTD has improved the efficiency of the analysis. Continuous laboratory Including staff involved in all levels of laboratories that develop quality systems in both the training field. Expertise Test And the ability of the laboratory

Comparison between laboratory results with ISO / IEC 17025: 2005 certification and laboratory monitoring. And continuous management review consistently. To comply with international accredited standards.

In academic and administrative systems. And support resources needed to operate. To support capacity expansion and research and development. For customer satisfaction and maximum benefit According to the quality policy statement, adhere to the following:

BIC LaboratoryCertify audit results Satisfy customer satisfaction.Improve with expert development. Complies with international standards.