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Custom Production Isolators & RABS

Our main specialization is the custom production of isolator technology and RABS. We have been providing this expertise since 2004. We approach each customer individually and thanks to our own design department and production we respond flexibly to our customer’s specifications and requirements. Our customer solution stands out for its well-thought-through design solution.

Utilising the highest quality materials, TIMOTEC’s isolators are built with precision. Constructed from robust stainless steel AISI 304 and AISI 316L, they ensure long-lasting performance across a wide range of demanding pplications, including weighing, sampling, handling materials, sterility testing and others. Fully certified in accordance with current standards (GMP, FDA, ISO, etc.), the isolator technology complies with the highest degree of pharmaceutical safety standards.

 

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Custom Production Isolators & RABS
  • Individual customer care thanks to our own design and development department
  • Flexible implementation of specific customer requirements
  • Well-thought-out designs and functional solutions
  • Precise manufacturing to the highest quality standards
  • Use of robust AISI 304 and AISI 316L stainless steel, 3 mm
  • High resistance to demanding conditions of use (cleaning agents, decontamination)
  • Possible integration of external devices

Delivery Process

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1. R&D

Research and development (R&D) in isolator technology manufacturing focuses on continuous improvement and innovation in the protection of personnel, products, and the environment.

2. Specification Consulting (URS)

We provide complete solutions on the basis of an analysis of your requirements and needs including pricing, description of our quotation and the subsequent processing of your order.

3. Mock-up

Your order is passed on to the design department. For an individual specialised customer requirement we develop a 3D proposal or a mock-up model for testing and optimisation of equipment ergonomics.

4. Production

We have our own isolator production facility in the Czech Republic. We are able to respond quickly and flexibly to meet your individual requirements thanks to the close cooperation of our production, design and commercial teams.

5. FAT Test

A Factory Acceptance Test (FAT or in brief “acceptance”) is performed on the installation site in the presence of the customer after the isolator is completely fabricated. The customer may invite an independent expert to the FAT test. Possible changes arising during testing are then incorporated.

6. Logistics

Thanks to our own logistics department and in co-operation with logistics and transport companies we are able to deliver products safely, reliably and on time.

7. Installation

The installation of your isolator is executed by our thoroughly trained employees or certified partners on the site of operation. According to the type of isolator and dimensions of the building access openings we transport either a completely assembled isolator or one disassembled into smaller parts which are then subsequently assembled.

8. SAT Test

Our expert team performs complete testing, control and other tasks necessary for validation of the installed equipment according to internationally recognized rules and procedures. Our staff can provide periodical check-ups and re-validation of your equipment.

9. IQ, OQ, PQ Validations

Documented verification that systems and equipment can operate effectively and reproducibly according to the approved manufacturing process and product specifications.

10. Maintenance

For ensuring smooth function of your isolator, the BLOCK® service team performs all service and maintenance operations on your request. We also provide consumable materials, e.g. gloves, hydrogen peroxide or other required components.

Laminar Isolators
Laminar isolators are designed to create a clean and sterile environment and to protect the product being processed or the operator.
  • Cleanliness class: A
  • Tightness class 3: according to ISO 10648-2.
  • Laminar flow: 0.45 m/s ±20% (864–1533 h⁻¹) depending on the chamber volume.
  • Construction material: shell material – AISI 304 stainless steel; chamber – AISI 316L stainless steel and plastics (certified, FDA CFR 21).
  • Operation in mode: overpressure or underpressure.
  • H₂O₂ decontamination option: separate chambers with separate ventilation systems.
Turbulent Isolators
Suitable for manufacturers of active pharmaceutical ingredients (API category OEB-6) and oral solid dosage forms (OSD). Ensures safety for both the production team and the product.
  • Cleanliness class: C
  • Tightness class 3: according to ISO 10648-2.
  • Turbulent flow: 5–40 exchanges/hour.
  • Construction material: shell material – AISI 304 stainless steel; chamber – AISI 316L stainless steel.
  • Operation in mode: overpressure or underpressure.
  • H₂O₂ decontamination option: separate chambers with separate ventilation systems.
Proprietary R&D.
That Lets You Focus on What Matters.
Our R&D department, in cooperation with research institutes, focuses on continuous improvement and innovation in isolator technology. We strive to constantly enhance our product range, while also developing custom solutions tailored to our customers’ specific needs.
  • For our customer, we developed Isolator workplace with turbulent flow for the preparation of solutions and handling of high API category OEB6
  • We have recently launched a Cell and Gene Therapy Device - ATMP.
  • We have been working on a development project A system for real-time monitoring of aseptic production of medicinal products for gene therapy.
Standard Equipment
Chamber
  • Fully welded working chamber
  • Easy-to-clean design
  • Sloped bottom with valve
  • Safety glass
  • Tilting front glass
  • Safe glove change
  • Cable ganguages
Control system
  • HMI panel
  • Sensors (temperature, air)
  • Visual and audible alarm
  • Pressure safety valve
  • Main switch
Standard Equipment
Equipment
  • Inflatable seal
  • Built-in LED lights
  • Hanging shelf system
  • Laminar frame
  • Perforated grates
  • Distribution piping for H₂O₂
  • Material pass-through
  • Tri-clamp validation port
  • Sockets for powering additional equipment
  • Foot switch
  • Sliding door
  • Shower
  • H14 HEPA filters
  • Single gloves
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