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:
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.
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
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.
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.
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 | |||
| ISO 14644-1 | 5 | 6 | 7 | 8 |
| BS 5295 | E/F | G/H | J | K |
| Federal standard 209E | 100 | 1000 | 10000 | 100000 |
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.
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.
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!
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.
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.
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.
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
Specificații tehnice
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.
Specificații tehnice
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.
Gas-liquid chromatography is a method of separating a mixture into its constituent parts for analysis. Capillary tubes used in gas-liquid chromatography processes can become coated in unwanted residue, oils or oxides, and thus require cleaning. The customer uses a mixture of water, isopropanol and formic acid, which runs down through the tubes and works to dissolve the unwanted material and carry it away, cleaning the tubes in the process. This GP oven has been modified to have a stainless-steel construction to provide greater resistance against attack from the formic acid contained within the customer’s cleaning solution. As the cleaning solution contains the solvent isopropanol, to protect against any dangerous build-up of explosive vapours, the oven is fitted with an air circulation fan to ensure a constant flow of fresh air into the oven chamber. An explosion relief panel is included as a secondary safety measure. Features:
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:
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:
