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Medical Device / Pharmaceuticals

Used in both production and testing, Carbolite Gero manufactures a range of class leading reliable furnaces and ovens for the pharmaceutical industry and medical devices sectors.
Core competencies for supplying into this market include:

  • Temp Ranges: Ambient to 3000 °C
  • Clean Room and non Clean Room Solutions
  • Modified Atmosphere and Air
  • Laboratory and Industrial

Regulation Compliance

Compliance with industry standards is a core requirement for many markets and is especially critical in the pharmaceutical & medical device sectors. We offer solutions to meet most standards for example: Data logging compliant to United States Food and Drug Administration (FDA) regulation 21 CFR Part 11, regarding the trustworthiness and reliability of electronic records and signatures.

For your specific requirements please get in touch.

Calibration

As part of compliance with industry regulations all Carbolite Gero's equipment can be calibrated to a range of standards including UKAS, ASTM and all relevant National Standards.I

If you would like to speak to our service team to discuss pre-existing equipment or to talk to us about a new application - please get in touch

Traceability, Data-Logging Software & Connectivity (IoT)

Using hardware and software that is both encrypted and incorruptible, Carbolite Gero offer solutions to ensure the traceability and security of processes in the pharmaceutical industry. Data logger, compliant to United States Food and Drug Administration (FDA) regulation 21 CFR Part 11, regarding the trustworthiness and reliability of electronic records and signatures.

Batch recording is available where required and subject to the type of data logging hardware installed. Solutions include: Basic temperature control, touchscreen basic, full PLC and all with connectivity to SCADA on request.

IQ/OQ/PQ

Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are 3 independent procedures.

Carbolite Gero have the ability to offer or assist, on request any IQ/OQ documentation required for our products.

Clean Room Classifications

It is a common requirement for ovens and furnaces working in medical and pharmaceutical to be housed in a clean room environment.
Classifications vary depending on the product and regulations surrounding the product.  

Carbolite Gero have a range of products suited to both high-end class 5 applications as well as less stringent offerings.
To ensure your product is the best fit please contact one of our agents.

Standards & Classifications

StandardsClassifications
ISO 14644-15678
BS 5295E/FG/HJK
Federal standard 209E100100010000100000

Introduction to Ovens for Non-Cleanroom and Class 8 / K / 100,000 Applications

The first range of solutions are for use in predominantly non clean room environments.  These can however be used in clean room classes where the requirements are not as stringent such as Class 8 / K / 100,000.   Standard solutions are available that can work in air as well as in a modified atmosphere.  The broad range of equipment and sizes offered allows for small batch flexibility where it is needed.

 

Výhody produktu World class temperature control

  • World class temperature control
  • High performing insulation for reduced energy usage and environmental impact
  • Designed for long service life to deliver a significant return on investment
  • Optional simple to use touchscreen interface
  • Stainless liners (get in touch to discuss specific grades)

Aplikácie

The most basic use of a laboratory oven is for drying and sterilising equipment, often glassware. Laboratory ovens can also be used for heating, dehydrating, or softening samples, as well as numerous other laboratory applications across various industries. Industries in which laboratory ovens are invaluable pieces of equipment include civil engineering, the technology industry, and healthcare.

Introduction to Ovens for Cleanrooms

Our oven solutions can be built to meet the highest requirements for cleanroom applications.  Carbolite Gero have a wealth of experience in working in this field to ensure airflow characteristics are optimised for optimal thermal performance without generating excessive amounts of dust during operation. If you need more information please get in touch to talk to one of our technical experts!

Výhody produktu

  • HEPA filters on request
  • Sealed liner for air quality control
  • Modified circulation fan for reduction of airborn particles 
  • World class temperature control
  • High performing insulation for reduced energy usage and environmental impact
  • Designed for long service life to deliver a significant return on investment
  • Optional simple to use touchscreen interface
  • Stainless liners (get in touch to discuss specific grades)

Aplikácie

The most basic use of a laboratory oven is for drying and sterilising equipment, often glassware. Laboratory ovens can also be used for heating, dehydrating, or softening samples, as well as numerous other laboratory applications across various industries. Industries in which laboratory ovens are invaluable pieces of equipment include civil engineering, the technology industry, and healthcare.

Introduction to Pass Through Oven and Furnaces

Furnaces, in particular, are not well suited to clean room applications due to their usage of linting and porous insulation materials. To address this Carbolite Gero have built furnace systems for the pharmaceutical and medical sector that allow the user to access the furnace aperture in the cleanroom whilst keeping the furnace body outside the cleanroom often in the “grey area”. The interface with the clean room is via a flanged interface on the front of the furnace assembly.

Image of through wall construction furnace
Image of through wall construction furnace
Image of pass through oven
Image of pass through oven

Preventative Maintenance

Having invested in a quality CARBOLITE GERO product you can ensure it continues to deliver the outstanding performance you expect. The life and performance of our furnaces or ovens can be extended and maintained with regular servicing and partial refurbishment such as replacing worn linings to boost performance and prolong usage.

Examples of Carbolite Gero furnaces and ovens in the pharma / medical device sector

  • Heat treatment of plastic tubes for use in intrauterine contraceptive implants (IUDs).
  • Part of an automated system for the testing of hair dyes
  • Cleaning capillary tubes used in gas-liquid chromatography
  • Heating High Performance Liquid Chromatography (HPLC) columns
  • Production of synthetic bone materials
  • Manufacture of synthetic bone allografts
  • Heat treating surgical cauterising equipment
  • Pyrolysis of organic materials
  • Synthesis of pharmaceutical materials
  • Heat treat vascular stents that are carried on mandrels
  • Calcination
  • Inert atmosphere tempering of steel for dental prosthesis supports
  • Ashing of pharmaceuticals
  • Produce metallic porous foams used for medical implants
  • Ashing of raw chemicals that will be pre ignited with sulfuric acid.
  • Pharma compendium heavy metal testing
  • Sterilising & depyrogenation of bottles
  • Heating vacuum / Dewar flasks used by analytical microbiologists
  • Heat treatment of medical components.

Custom Design Examples for pharma / medical

The heat treatment of plastic tubes for use in intrauterine contraceptive implants (IUDs). The process of heat treatment removes chemicals found in the plastic that may not be suitable for implantation in the human body. Time saving loading system: racks are manoeuvred into position on trolleys and pushed directly into the oven chamber.

Quality and reliability: Data logger, compliant to United States Food and Drug Administration (FDA) regulation 21 CFR Part 1

Technické údaje

  • Custom Design Cleanroom Oven
  • Chamber capacity of 1800 litres
  • Maximum operating temperature 200 °C

 

Medical implants have to comply with strict quality requirements and combine a wide variety of physical and biological properties. Ceramic and metal structures meet these requirements perfectly and enable the mass production of standard parts or one-off components for a specific patient.

The HTK 80 MO/14-1G chamber furnace has been designed to debind and sinter medical implatns and does this with full automation, the sinter stage being carried out in a controlled oxygen free atmosphere. With both the heating elements and insulation constructed from molybdenum, this metallic furnace is capable of maintaining inert atmospheres of the highest possible purity and achieving high vacuum levels in the region of 5 x 10-6 mbar.

Technické údaje

  • Chamber capacity of 80 litres
  • Maximum operating temperature 1400 °C

Designed for heating High Performance Liquid Chromatography (HPLC) columns. The oven is used for applications requiring temperatures above ambient.  The higher temperature provides improved reproducibility, higher separation performance, and reduced analysis time.

Equipped with three access ports on each side panel and a circulation fan providing forced convection in the roof. The chamber base is seam welded for liquid tightness and cross-folded with a central drain hole. A silicone rubber drain pipe is positioned 500mm from the base at the rear of the cabinet. The chamber interior is made of brushed 430 grade stainless steel and is well insulated using high quality fibre insulation.

  • Max Temp 200°C
  • Control setpoint limit 100°C
  • O/T setpoint limit 115°C
  • Internal dimensions (mm) 500H x 130W x 130D
  • External dimensions (mm) 750H x 255W x 375D
  • Air Circulation Forced convection by roof fan
  • Temp. Sensors Type K Thermocouples
  • Heating Power 750 Watts
  • Power Supply 230V single phase/neutral/earth
  • 50/60Hz

Chromatografia plyn-kvapalina je metóda separácie zmesi na jej zložky na účely analýzy. Kapilárne trubice používané pri chromatografii plyn - kvapalina sa môžu pokryť nežiaducimi zvyškami, olejmi alebo oxidmi, a preto si vyžadujú čistenie. Zákazník používa zmes vody, izopropanolu a kyseliny mravčej, ktorá steká cez trubice a pôsobí tak, že rozpúšťa nežiaduci materiál a odvádza ho preč, pričom čistí trubice. Táto rúra GP bola upravená tak, aby mala konštrukciu z nehrdzavejúcej ocele, ktorá zabezpečuje väčšiu odolnosť proti pôsobeniu kyseliny mravčej obsiahnutej v čistiacom roztoku zákazníka. Keďže čistiaci roztok obsahuje rozpúšťadlo izopropanol, na ochranu pred nebezpečným hromadením výbušných pár je pec vybavená ventilátorom s cirkuláciou vzduchu, ktorý zabezpečuje stály prívod čerstvého vzduchu do komory pece.  Ako ďalšie bezpečnostné opatrenie je k dispozícii nevýbušný panel. Vlastnosti:

  • Objem komory 450 litrov
  • Maximálna prevádzková teplota 300 °C

This unit has been designed to be used as part of an automated system for the testing of hair dyes, focusing on the drying and ageing of hair samples. Human hair samples are dyed, then robot arms insert the hair into the oven for drying. This process is then repeated so that the customer can record how long it takes before the colour fades. This customised oven features 6 inward opening letterbox-style flaps, designed to allow robot arms easy access into the chamber to deposit and remove test samples. The internal shelves incorporate rectangular cut-outs and positioning lugs to ensure the customer’s sample trays are held securely in place. Each shelf also includes a drip tray to catch any overspill from the sample trays. Features:

  • Chamber capacity of 16 litres
  • maximum operating temperature 150 °C

Heat treating the ends of surgical cauterising equipment used to stop bleeds or remove small unwanted growths. The customer required a set of 4 custom ovens capable of running at fixed temperatures of either 177°C or 343°C, and suitable for installation within an ISO class 7 clean room environment. This solution features a double-sided chamber with a single hinged door at the rear for manual loading, and an electrically operated automatic front door designed to accommodate robotic loading. The automatic door opens by first reversing away from the oven chamber, then sliding vertically down the front of the oven frame. The two sides of the chamber are each capable of holding one small pallet and are separated by a mesh divider. Features:

  • Chamber capacity of 300 litres
  • maximum operating temperature 400 °C