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Dec Group Testing Facilities, process improvement and validation

Testing Facilities

As an essential element of Dec's dedication to quality, customers are provided with the ability to test their products, or a suitable test product, using our in-house test plants, pre-purchase. 

Tests are prepared and carried out by Dec's specialists, and of course, the customer is welcome to join us on site to observe the process.

From powder handling including powder characterization to SMEPAC testing and particle size analyses, Dec has a full range of facilities and equipment as well as skilled technicians to support your needs.

MC200 Test Isolator, Dec Group Testing Facility

SMEPAC - Standardized Measurement of Equipment Particulate Airborne Concentration

Dec demonstrates containment performance through SMEPAC‑compliant surrogate testing in its own positively pressurized ULPA‑filtered cabin, using micronized lactose or naproxen sodium and full air‑sampling equipment such as SKC Sidekick pumps. The protocol identifies potential breach points - airlocks, endless liners, exhaust outlets -where static samplers are positioned, including on the operator.
All air and surface samples, taken before and after testing, are analyzed by an NVLAP‑accredited laboratory using an HPLC method. In line with SMEPAC guidelines, up to three consecutive runs are performed, typically collecting around 20 samples with a detection limit of 2 ng per filter.

Product trials include the following equipment and possibilities:

  • Powder transfer 

  • FIBC discharge and filling, drum and bag handling 

  • Mixing/Blending/Homogenizing

  • Micronizing/Milling including particle size analyses

  • Various crushing and delumping systems

  • Sampling

  • Liquids handling

  • Microdosing (from 1 mg)

  • Powder sterilization

  • SMEPAC containment performance testing 

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コンテインメント封じ込め​技術

プロセスアイソレーターおよび封じ込めシステム - ダウンフローブース - 放射線封じ込め

2d695c77-fd54-41b3-981b-a5b2695eccd5.jpg

充填 技術

無菌充填ライン - 液体および粉体充填 - 研究室スケールからフル生産まで

Office Worker Focused

エンジニアリング

エンジニアリングソリューション

スキッドマウント型実験室やパイロット環境から本格的な生産まで

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粉体ハンドリング 技術

バルクハンドリング - 搬送 -

調剤/投与 - 混合 -サンプリング - 梱包 - 封じ込め

_MG_7588_jpg.jpg

連続生産 技術

連続フローケミストリーソリューション

反応 - 抽出 - 蒸発 - 蒸留 - 結晶化 - ろ過 - 乾燥

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コンテインメント封じ込め​技術

プロセスアイソレーターおよび封じ込めシステム - ダウンフローブース - 放射線封じ込め

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