Hermetyzacja

Firma DEC dostarcza zintegrowane systemy sterylne, zapewniające pełną hermetyzację i separację procesu od otoczenia.
W skład wchodzą zarówno zwykłe izolatory farmaceutyczne (szafki rękawicowe) czy szafki rozładunku worków zgodne z systemami „DEC ISOCHARGE” oraz "DEC ISOTUBE", które całkowicie uniemożliwiają kontakt obsługi z produktem (opisane w zakładce "szafki rozładunku worków STC), jak i skomplikowane systemy separacji i hermetyzacji z autonomicznymi układami przenoszenia pneumatycznego.

  

*  TWA = 8-godzinny średnio-ważony czas ekspozycji (TWA) - to średnia wartość narażenia osoby na ekspozycję w ciągu 8-godzinnej zmiany roboczej.

*  DCS - Drum Containment System*

Opatentowany przez firmę DEC system "DCS" = Drum Containment System, wstosowany w transporcie proszków i antyskażeniowych systemach procesowych  - to pasywny system bezpieczeństwa polegający na otwieraniu i zamykaniu beczek zawierających szkodliwe płyny i proszki, a także na ich opróżnianiu lub napełnianiu, w warunkach całkowitej separacji produktu oraz jego oparów czy śladów cząsteczkowych od otaczającego środowiska i miejsca pracy. System "DCS" zapewnia pełną hermetyzację i separację pojemnika oraz jego zawartości od otoczenia, w czasie procesów związanych z jego opróżnianiem czy napełnianiem.

* cGMP = 3',5'-cykliczny guanozynomonofosforan – organiczny związek chemiczny z grupy nukleotydów, cykliczny guanozynomonofosforan, zawierający grupę fosforanową łączącą pozycje 3'-O i 5'-O. Związek ten bierze udział w wielu reakcjach biochemicznych jako element transdukcji sygnału

* GMP = Dobra Praktyka Produkcyjna (ang. Good Manufacturing Practice, GMP) – oznacza zestaw standardów stosowanych w produkcji przemysłowej, a coraz częściej także w gastronomii, zapewniająący wysoką jakość, czystość użytych surowców i komponentów gotowego produktu. Standardy GMP zapewniają pełną kontrolę nad jakością i pochodzeniem surowców. Standardy GMP opracowano pierwotnie dla przemysłu farmaceutycznego. Obecnie stosowane bywają przez firmy kosmetyczne, producentów suplementów odżywczych itp.

* Isolator, drybox, glovebox (ang.) = komora rękawicowa, izolator farmaceutyczny

STC (Sack Tip Cabinet=Sack Tipping Station) = bezpyłowa szafka rozładunku worków, rozworkowywacz

* HEPA (High Efficiency Particulate Air filter) – wysokosprawny filtr powietrza służący do dezynfekcji powietrza. Filtry HEPA stosowane są w lożach, boksach, skrzynkach lub pomieszczeniach do pracy w środowisku jałowym.

In pharmaceutical manufacture containment performance is critical to minimize operator exposure and process cross contamination.

TEKPRO DEC GROUP isocharge isotube isodrop isolator systemsCentral containment goals are based on the need to give the operator optimum protection based on the product’s containment band, maintaining good cGMP conditions, eliminating cross contamination, and reducing clean up requirements.

Process integrated containment technology provides solutions for both potent and aseptic compounds, from simple glove bags and flexible isolators through to extremely complex fully integrated process isolators with dedicated air handling systems.

TEKPRO DEG GROUP isotube - komora rękawicowa izolator farmaceutyczny

DEC ISOTUBE

The DEC Isotube product transfer system is a low cost option for the safe loading and charging of drums of highly active pharmaceutical ingredients.

Equally effective when loading a process vessel or other charging application such as the Powder Transfer System, the DEC Isotube provides a high level of containment together with control over environmental conditions within the isolation system.

The system comprises a single vessel charging glove box, which can be connected directly to the vessel or application to be charged with powder from a drum or keg of any size. The DEC Isotube is equipped with a drum bag in/ bag out system (using endless liner technology) to ensure contained loading both in and out of the isolator.

A scale in the drum access chamber makes the system equally ideal for dispensing.

The ‘DEC Isotube’ provides a high level of containment together with control over environmental conditions. This ‘Clean Air Transfer System’ is equipped with a drum sealing system ensuring contained drum loading and powder charging.

We are able to offer a number of drum sealing options for a wide range of drum diameters.

TEKPRO DEG GROUP isotube - komora rękawicowa izolator farmaceutyczny• Closed charging of drummed powder in a Clean Air Environment
• High containment <1μg/m³ with HEPA filtration, allows ‘Shirt Sleeve’ Operation
• Capable of supporting an inerted atmosphere for handling low MIE or degradable products
• Safe waste removal through Continuous Liner Port
• Gravity discharge or integration with PTS
• Operation under controlled atmospheric GMP conditions

Features

  • Accommodates all drum sizes
  • Simple to operate
  • Flexible
  • Vessel charging
  • Product dispensing
  • Ergonomic
  • Containment to below 1μg/m3 per hour
  • Multiple charge points
  • Fully cleanable
  • Works with lumpy and agglomerated products
  • Charging by gravity or active transfer with a PTS Powder Transfer System

 

DEC ISODROP

TEKPRO DEG GROUP isodrop - komora rękawicowa izolator farmaceutycznyThe single or multi chamber ‘DEC Isodrop’ Containment Glovebox enables safe emptying, sampling and general handling of powder products. Suitable for integrating with filter dryers, ovens, centrifuges, etc. Options include: Glove Safety Barrier, Oxygen Monitors, RTP's, Continuous Liners and many more.

The ‘DEC Isodrop’ in conjunction with DEC’s PTS Feeder system provides accurate target weight filling of IBC/Drums in a contained manner.

• High containment <1μg/m³ with HEPA filtration, allows‘Shirt Sleeve’ Operation
• Venturi or Exhaust Fan options for venting the liner
• Full CIP capability
• Capable of supporting an inerted atmosphere for handling low MIE or Degradable Powder
• Suitable for a wide range of powder handling discharge arrangements
• Possible integration of supplier controls package (filter dryer as shown)

DEC Isodrop:TEKPRO DEG GROUP isodrop - komora rękawicowa izolator farmaceutyczny

  • Safe powder discharge from filter dryers, centrifuges, etc.
  • High containment (< 20 ng/m3)
  • Integrated sampling, milling or dispensing
  • Full heel removal
  • Contained pack-off to nano gram levels
  • System available with closed loop transfer to secondary processes
  • Solid or flexible design
  • Aseptic or non-aseptic versions
  • Full CIP/SIP options

The DEC Isodrop is ideal for product discharge from R&D to full size production units and can be used simultaneously as a complete dispensing system. Thanks to its high containment level, it is the perfect solution for sterile and highly toxic products or both. Based on 3D solid model designs, these ergonomically assessed systems are critical when dealing with the removal of toxic or sterile products from filter dryers or similar devices.

The isolator is equipped with automated control of the working environment and is supplied with HEPA filtration (EU14) or ULPA filtration for sterile systems. They can be configured in either disposable flexible units or solid systems. Dependent of the size of the system and the filter dryer valve configuration both glove port and half suit systems are available. The operator’s access into the isolator can be through simple two glove port arrangements up to multiple glove port processes with integrated pack-off into drums or liners or through half suit installations to cope with the large plug valves found on the older filter dryer systems.

The DEC Isodrop can be linked to a variety of DEC Systems for contained product sampling, transfer and pack-off processes with weighing options.

Features

  • High level of containment <20 ng/m³
  • Quick assembly and simple operation
  • Safe for operator and environment
  • Works under inerted atmosphere for handling low MIE powder
  • Fully CIP and SIP with integrated VHP® system for a high sterility assurance level
  • Process integration to GAMP5 and complete CFR 21 Part 11 compliance available
  • Connection to computer-controlled BMS (Building Management System) possible
  • Suitable for a wide range of powder handling discharge arrangements

Options

  • Single or multi chamber glovebox
  • Flexible or solid version
  • Glove safety barrier, oxygen monitors, RTPs
  • Continuous liner integration

 

The alternative twin a chamber ‘DEC Isodrop’ provides integral contained pack-off, for powder products with weighing options available.

More simple Pack-off options include direct PTS transfer to a Continuous Liner with HEPA Filtration.

 

 

 

DEC ISOCHARGE

TEKPRO DEG GROUP isocharge - komora rękawicowa izolator farmaceutycznyFor Rapid Powder Charging with Room Air

• Fast, Open Charging of Bags and/or Drums
• High Containment >1μg/m³ with HEPA filtration, allows ‘Shirt Sleeve’ Operation
• Automated or Manual Airflow Control options available
• Full CIP capability
• Charging Hopper options available for all powders, lumpy, sticky or wet
• Integrates seamlessly with the PTS

‘Open Manway Charging’ is no longer acceptable, but a new development being successfully used by Dec clients worldwide, is the ‘DEC Isocharge’. Combining the open aspects of a Laminar Flow Booth with a Glovebox Isolator to enable the ‘Rapid and Safe Charging’ of powder products.

  • Fast operation for multiple bag emptying
  • Safe handling of toxic, sticky or lumpy powders
  • High containment (<1μg/m3)
  • Stand-alone unit
  • Cost effective
  • Mobile
  • One unit can be used to charge multiple receiving vessels

The revolutionary DEC Isocharge is a low cost method of both dispensing and charging bags into reactors or receiving systems via the PTS Powder Transfer System*. The DEC Isocharge combines the advantages of isolation and laminar flow technology, providing high containment of < 1μg/m3 per 8 h TWA.

The station’s chamber is open to the side allowing easy bag introduction. A simple door only needs to be closed during WIP to prevent splashes. All WIP fluids can be drained from the chamber via the PTS Powder Transfer System* into the reactor, which also cleans the transfer hose and the PTS.

Using the gloves the operator will move the bag of powder into position on the charging bars above the integrated hopper. The bag is then split and the powder emptied through the bars. The empty bag is disposed through the adjacent continuous liner bag-out port. The operator now starts the PTS and charges the required amount of powder to the vessel.

On the other side of the station opposite the bag entry point is an exhaust plenum. A HEPA filtered exhaust is located on top of the plenum, connected to the exhaust fan. The fan is available with a simple manual damper or can be fully automated depending on requirements.

*patented

Features

  • Containment levels up to <1μg/m³
  • Fully surrogate tested and can be operated with closed or opened door
  • Safe for operator and environment
  • Fast emptying of multiple bags
  • Good working ergonomics
  • Good visibility
  • Integrated fan including control options
  • Continuous liner waste Bag-Out Port
  • Safe Change HEPA Filtration
  • WIP facility

 

Options

  • Precise dispensing with integrated scale
  • Assistance for heavy bag handling
  • CIP with independent wash down facilities
  • Integration of delumper for lumpy and agglomerated products

Design

  • 0.7 m/s face velocity
  • AISI type 316L stainless steel, glass and EPDM
  • Other materials available (HC22, internal coating etc.)

Optional ‘Drum Charge Adaptor’, suitable for a range of drum sizes.

Can be easily adapted for ‘Multiple Vessel Charging’ via the proven Dec PTS (patented) Technology.

Internal view of the ‘DEC Isocharge’ utilizing both Laminar Flow and Glovebox Technology to allow safe and rapid powder charging.
Our ‘Clean Room Manufactured and Packed’ for optimum cleanliness, Continuous Pack-Off Liner is folded ‘Top to Bottom’ to give a greatly increased capacity and high containment, <1μg/m³.
Dec’s own, purpose built, SMEPAC compliant facility for Containment Testing. A twin chamber ‘DEC Isodrop’ facilitates both the contained emptying and pack-off of product from a vessel, such as a filter dryer.
The ‘DEC Isotube’ for fully contained and clean transfer of products in drums, in combination with DEC's dense phase Powder Transfer System PTS or by gravity.

Be it for operator or product protection, the DEC Group has a solution for all your powder handling requirements.

 

* TWA = 8-hour Time Weighted Averages (TWA) - are an average value of exposure over the course of an 8 hour work shift.

* GMP = A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

* cGMP = Cyclic guanosine monophosphate (cGMP) is a cyclic nucleotide derived from guanosine triphosphate (GTP). cGMP acts as a second messenger much like cyclic AMP. Its most likely mechanism of action is activation of intracellular protein kinases in response to the binding of membrane-impermeable peptide hormones to the external cell surface.

 

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