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PT. Pharma Test Indonesia at Lab Indonesia 2014

PHARMA TEST INDONESIA had participated in Lab Indonesia Exhibition starting from 7th to 9th May 2014. We have a booth at N10. Our CEO from Germany Mr. Bjoern Fahler came to support us in this exhibition. During the event, we displayed 3 main instruments from Pharma Test such as Disintegration Tester, Hardness Tester and Friability Tester. We also launch our new generation of Dissolution Tester type PTWS 800D which equipped with a new firmware and now available with Large Colorful Touchscreen display. This new instrument will be ready for the market in June 2014.

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U.S. Pharmacopeia Seminar in Jakarta 6 March 2014

On Thursday 6 March 2014, PT. Pharma Test Indonesia has successfully organized a Seminar from U.S. Pharmacopeia with the topic “Dissolution: USP PVT Dissolution Instrument Qualification”. The Seminar was held in Novotel Mangga Dua Square and attended by 110 participants from 59 Pharmaceutical Companies in Indonesia. The main issue of this seminar is to discuss Dissolution Best Practice and how to perform a PVT (Performance Verification Test) from the USP point of view.

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LABASIA 2013 EXHIBITION REVIEW

Lab Asia 2013 Exhibition was held in Kuala Lumpur at 8-10 October 2013 located in Putra World Trade Center. Lab Asia is an exhibition that specified for Laboratory Equipment. In this exhibition, PT. Pharma Test Indonesia sent a representative to meet the customers and our agent in Malaysia. The agent of PHARMA TEST in Malaysia is Matrix Analytical Sdn, Bhd. Together with the Lab Asia, there was also Chem Asia Exhibition that took place at the same venue from 8-9 October 2013. Chem Asia 2013 was more specific for raw material and chemical.

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Fully Automatic Powder Tester Installation

Hi All,

This month (August 2013) we have just installed a new unit of Fully Automatic Powder Tester PTGS-4 at one of our customer site. The number of this instrument in Indonesia increased within the last 2 years. This indicates the importance to test all basic parameters from every incoming powder or every powder used. In Indonesia, mostly the customer test the characteristic of powder using a funnel and the time recorded manually. The manual testing is not too accurate and also increases the uncertainty of the result caused by human error. By using the automatic powder tester, we hope to increase the effectiveness and also the accuracy during powder testing.

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PHARMA TEST Asian Sales Seminar in Phuket February 2013

Hi visitors, di posting ini kami akan menceritakan mengenai event Asian Sales Seminar yang diadakan oleh PHARMA TEST di Phuket, Thailand pada bulan Februari 2013 dan berlangsung selama 3 hari. Sebenarnya agak sedikit terlambat review ini, tetapi seperti kata pepatah “Lebih baik terlambat daripada tidak sama sekali”. Oleh karena itu kami memutuskan untuk tetap membuat review ini. Acara merupakan acara rutin dimana para distributor PHARMA TEST di Asia berkumpul untuk mendapatkan update terbaru mengenai produk-produk baru Pharma Test dan juga untuk sharing pengalaman di masing-masing negara. Acara tersebut dihadiri oleh wakil dari Malaysia, Jepang, Thailand, India, China, Korea, Vietnam, Kamboja, dll.

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Biowaiver Monograph 2004-2012

Regulations on biowaivers already existed at that time, according to which an in vitro instead of an in vivo assessment could be used to assess bioequivalence for a new tablet or capsule, or a new formulation of an existing immediate release dosage form. On the basis of the in vitro assessment, a new drug product could be considered bioequivalent to its reference product, without having to perform a pharmacokinetic study in human volunteers. To generally describe the use of an in vitro assessment to waive the need for in vivo (bio) studies, the term “biowaiver” was coined. As this term was originally applied to waiving in vivo studies for registration of lower dosage strengths of drug products, the more precise term “BCS based biowaiver” is sometimes used to distinguish biowaivers based on BCS considerations from biowaivers used for the approval of lower dose strengths of a product.

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Mechanical Calibration for Dissolution by USP

Scope : The dissolution toolkit provides a description of best practices associated with the mechanical calibration and performance verification test for the USP basket and paddle dissolution apparatuses and test assemblies. The best practices have been developed based on experience gained by the USP laboratory (9, 13, 14, 15) and with suggestions from the USP Expert Committee on Biopharmaceutics. While not a standard requiring rigid compliance, the dissolution toolkit is intended to provide information aiding the dissolution laboratory in the effort to obtain valid dissolution testing results.

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Intrinsic Dissolution

This general information chapter Apparent Intrinsic Dissolution—Dissolution Testing Procedures for Rotating Disk and Stationary Disk 1087 discusses the determination of dissolution rates from nondisintegrating compacts exposing a fixed surface area to a given solvent medium. Compact, as used here, is a nondisintegrating mass resulting from compression of the material under test using appropriate pressure conditions. A single surface having specified physical dimensions is presented for dissolution. Determination of the rate of dissolution can be important during the course of the development of new chemical entities because it sometimes permits prediction of potential bioavailability problems and may also be useful to characterize compendial articles such as excipients or drug substances. Intrinsic dissolution studies are characterization studies and are not referenced in individual monographs. Information provided in this general information chapter is intended to be adapted via a specific protocol appropriate to a specified material.

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Dissolution Vessel

Used in the private or public USP Performance test, dissolution testing plays an important role in both product development and quality assurance for nonsolution oral dosage forms. The dissolution procedure itself, as described in USP General Chapter Dissolution , is sensitive and specific but requires special care in execution. Results of a recent USP collaborative study of new Lot P Prednisone Reference Standard Tablets indicate much higher reproducibility (interlaboratory variance) than repeatability (intralaboratory variance) (1, 2). To improve reproducibility, the USP Biopharmaceutics Expert Committee recommends careful IQ, OQ, and PQ (mechanical calibration), aswellasaPerformanceVerificationTest (PVT); the latter two typically are performed at six-month intervals. Several variables such as shaft rotation speed, shaft and vessel alignment, basket/paddle height, and bath levelness have been cited as factors that contribute to high variability of the dissolution procedure. Missing from this list are factors relating to vessel dimension and irregularities, which are the subject of this report.

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About Us

PT. Pharma Test Indonesia was established at the end of 2009. We are the subsidiary of Pharma Test AG (Germany) in South East Asia which supplies machines for Pharmaceutical Industry. As a part of Pharma Test commitment to Indonesian market, the company was established to fulfill the need for high quality testing equipments and supported with excellent after-sales service. Our company also supported the Pharma Test agents in South East Asia especially for the technical support.

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Contact Us

Anda bisa menghubungi kami untuk lebih detail terkait produk dan layanan kami.

PT. Pharma Test Indonesia
Komplek Mutiara Taman Palem
Blok H2/19, Cengkareng
Jakarta Barat 11730

Phone. +62 21 5694 6073
Fax. +62 21 5694 6073
Mobile. +62 851 00902797

Marketing: hans@pharma-test-indo.com
Technical Support: teknik@pharma-test-indo.com

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