Barrier Systems & Laminar Flow
With spreading of diseases being the talk of the century, containment had picked up even faster in the global pharmaceutical market on materials, operator and environmental protection, consideration toward increasing standards of safety, sterility assurance and regulatory compliance has never been higher.
Traditional containment/aseptic technologies such as Downflow Booths (DFB’s) Laminar Airflow systems (LAF), aseptic/containment Isolators and Restricted access barrier systems (RABS) are being enhanced by additional features providing greater product, operator or environmental safety technology.
Containment Isolators
Telstar has been supplying containment Isolators for operator protection for over 25 years, resulting in a very impressive portfolio of installed units located all around the world. Whether supplied as stand-alone Isolators for sampling or dispensing etc, or as integrated Isolator solutions for say tabletting or capsule filling, Telstar Isolators are designed with the operators’ requirements, comfort and safeguard at the uppermost.
A clear understanding of the actual application involved, is key to providing a containment Isolator that completely meets the demands of the client and process. With independently validated containment Isolator installations offering operator protection from <1µg/m3 to as low as 0.2ng/m3 (200picogrames), Telstar can offer unprecedented levels in terms of guarantees on the OEL.
Telstar is extremely proud of its’ achievements in containment Isolators and as a recognized market leader in this field Telstar continues to challenge the current boundaries in Isolator technology, to keep pace with the ever increasing demands laid down by the market.
Guaranteed Quality
Telstar has the expertise to meet industry rising challenges by offering an impressive range of containment Isolators, from single chambers to multi chamber systems accommodating where necessary a wide range of process equipment.
Telstar containment Isolators are predominantly derived from a standard of range mechanical and electrical components, coupled with a degree of customisation to match specific clients requirements. The equipment Telstar proposes balances optimum operator and product protection with cost – effectiveness and ease of use. Offering advanced ergonomic designs Telstar ensure that our clients receive a high quality standard of service which contributes to the smooth and satisfactory project completion.
Sterility Test Isolators
Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production batch. It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results.
False positive results are generally due to laboratory contamination from the testing environment or technician/technique error and cause additional work in terms of extra documentation required and adds significantly to cost as it delays or prevents release of the product for sale.
Telstar Pura Sterility Test Isolators are designed to avoid the risk of false results and to protect the product from both the process and externally generated factors that would compromise its quality.
The Telstar Pura range has been developed to cover a wide range of client’s needs. The units’ ability to provide a reliable aseptic environment for sterility testing and other aseptic processes is unquestioned. A minimum of log 6 reduction in spore forming micro-organisms is consistently achieved & validated using a BI challenge.
Engineering solutions
The Telstar Pura range comprises of five Sterility Test Isolators providing a reliable aseptic environment suitable for performing both direct inoculation and filter membrane sterility tests. With three base sizes and the option of a pass chamber, the Telstar Pura range is suitable for sterility testing from small batch to continuous production scale.
All Telstar Pura range Sterility Test Isolators provide a Grade A (ISO 4.8) positive pressure environment as either single pass directional flow or recirculatory unidirectional laminar flow designs. Manufactured to a high pharmaceutical standard from stainless steel with sealed glass vision panels, Telstar’s Pura range meets the high demands of GMP industry standards and stringent leakage criteria as required by ISO 14644-7.
As standard all Telstar Pura Isolators are PLC controlled and equipped with Telstar’s unique ionHP+ hydrogen peroxide based bio-decontamination system, providing rapid and effective sterilization of the Isolator and a validated six log reduction of viruses, spores and fungi. Alternatively third party systems can be fitted to fulfil specific user requirements.
Downflow Booths
With almost 50 years of experience in air handling technologies and a continuous investment in R&D, Telstar is pleased to provide equipment that can bring advanced levels of protection to those who work with potentially hazardous and toxic materials.
Telstar downflow booths offer a high level of operator, environment and product protection within the industry, used particularly where hazardous and toxics powders are processed.
Two different approaches (standard and custom-built modular series) allow Telstar to provide a perfect solution for your particular project.
Safety by design
- Triple protection; operator, product and environment
- Complete model in 3D
- Proven worldwide design
- User friendly
New Standard series
- Cost effective solutions
- Delivery time reduction
- Low maintenance cost
- Green technology
For customized units please refer to the Modular series
Modular series: Flexible design adapted to the process
Leaders in customizing fully integrated systems, working in partnership with the customer by understanding their application to provide the exact solution for each particular requirement.
- Complete range of accessories and options
- Integration of other equipment (scales, screens, HMI, lifters, etc.).
- Knowledge of the process.
- Explosion proof versions (gas and dust)
- Requested customization possible
Fully compliant
Telstar Barrier Systems are guaranteed to comply with relevant standards and demands set by the regulatory bodies to ensure conformance and client’s satisfaction, including:
- ISO 14644-1 Cleanroom & Associated Controlled Environment
- cGMP Guidelines (current Good Manufacturing Practices)
- ISPE guidelines (The Society of Pharmaceutical and Medical Device Professionals)
Aseptic Barrier Isolators
Telstar aseptic Isolators combined with third party equipment such as automated filling lines for liquids and powders, significantly reduce the risk presented by direct human intervention and are increasingly being prescribed by the pharma industry.
From complete filling lines to stand alone aseptic processes, Telstar aseptic Isolators are designed to supply solutions adhering to regulatory standards and GMP guidelines.
Attention to detail
Telstar aseptic Isolation solutions are predominantly derived from a standard of range mechanical and electrical components, coupled with a degree of customisation to match specific clients requirements. All Telstar aseptic Isolators incorporate recirculatory unidirectional laminar flow designs as standard, providing a Grade A (ISO 4.8) positive pressure environment.
Manufactured to a high pharmaceutical standard from stainless steel with sealed glass vision panels, Telstar’s aseptic Isolators meet the high demands of GMP industry standards and stringent leakage criteria as required by ISO 14644-7.
Telstar aseptic Isolator installations would typically include a validated hydrogen peroxide based bio-decontamination system providing a minimum of log 6 reduction; aseptic transfer methods for powders, components and liquids; temperature & RH conditioning; viable / non-viable particle monitoring equipment and a PLC controlled operating system with local HMI.
Restricted Access Barrier systems (RAB’s)
RAB’s are becoming increasingly popular within aseptic processing as they offer effective product protection by providing a high level of separation between operators and the critical aseptic core. By using a combination of a physical barrier and dynamic airflow, the product protection that it can provide approaches that of an Isolator and is often the barrier system of choice in some applications.
Open or Closed Restricted Access Barriers (oRAB’s / cRAB’s) are an important element in Telstar’s product portfolio and provide a viable alternative to Isolation technology where a leak tight option is not necessary but the need for enhanced product protection in a grade B room is still required.
Telstar RAB’s offer flexibility in design and fulfil current regulatory standards and GMP guidelines as required in today’s aseptic manufacturing facilities throughout the world.
Bespoke solutions
Telstar RAB’s combined with third party equipment such as automated filling lines for liquids and powders, significantly reduce the risk presented by direct human intervention and are increasingly being prescribed by the pharma industry.
Telstar RAB’s are predominantly derived from a standard of range mechanical and electrical components, coupled with a degree of customisation to match specific clients’ requirements. All Telstar RAB’s incorporate unidirectional laminar flow designs as standard, providing a Grade A (ISO 4.8) positive pressure environment over the critical aseptic area.
Telstar RAB’s installations would typically include; aseptic transfer methods for powders, components and liquids; temperature & RH conditioning; viable / non-viable particle monitoring equipment and a PLC controlled operating system with local HMI.
Laminar Air Flow Systems
Telstar offers a complete range of products with fan filter units to be wall or ceiling mounted, portable clean air units, room air renovations and laminar airflow modules, for a high level of product protection, used particularly when the products are sensitive to contamination.
The global size of the company means that Telstar has the capacity to handle vast scale, large value and high volume projects. Leaders in customizing fully integrated systems working in partnership with customer organizations to provide the exact solution for every particular requirement.
A complete range of accessories and optional extras allows a wide range of configurations to be built.
Safety by design
- Triple protection; operator, product and environment
- Creates a clean zone with minimal viable particles
- Complete model in 3D
- Proven worldwide design
Modular series: Flexible design adapted to the process
Leaders in customizing fully integrated systems, working in partnership with the customer by understanding their application to provide the exact solution for each particular requirement.
- Complete range of accessories and options
- Knowledge of the process
- Explosion proof versions (gas and dust).
- Complex customization possible
- Cost effective solutions
- Low maintenance cost
- Green technology
Mobile Transfer carts
- Product transfers in aseptic conditions
- Wireless solution (battery equipped)
- Providing ISO 5 aseptic environment
- Unidirectional flow; vertical or horizontal
- Designed for the particular transfer process
Laminar Air flow Modules for filling and packaging lines
- High standard aseptic environments.
- Pharmaceutical, food, cosmetic and packaging industries
- Complete 3D design and integration with the process equipment
- Modular and compact solution
- Possibility to include restricted access barriers (glove ports, safety glasses, etc).
Fan Filter Units
- Designed to provide filtered clean air over a specific area
- To be installed in wall (FFU series) or ceiling (AVF series)
- Create a positive pressure relative to the surrounding rooms
- Low noise level, low profile and high performance
Fully compliant
Telstar systems are guaranteed to comply with relevant standards and demands set by the regulatory bodies to ensure conformance and clients’ satisfaction, including:
- ISO 14644-1 Cleanroom & Associated Controlled Environment
- cGMP Guidelines (current Good Manufacturing Practices)
- ISPE guidelines (The Society of Pharmaceutical and Medical Device Professionals)
SAS Pass Through Boxes
The requirements for processes involved in the manufacture of pharmaceuticals and similar regulated products are becoming increasingly demanding, which in turn requires the use of equipment which is able to guarantee the quality of final product.
Telstar SAS systems are specially designed for the safe transfer of materials between classified areas or between a classified area and a non-classified area. Telstar SAS systems can be configured to bio-decontaminate the materials being transferred; thereby reducing the burden on the exit atmosphere.
Telstar provides 3 types of SAS
Pass Through SAS
Equipment specially designed for the transfer of materials between classified areas or between a classified area and a non-classified area with no filtration system.
The system keeps the door blocked where the charge has been carried out, allowing the removal of the material from the other door; with the aim of not contaminating the clean area. The product in transfer is subjected in a controlled time of UV light radiation.
HEPA Filtered SAS
Equipment specifically designed for the transfer of materials between classified areas or between a classified area and a non-classified area, with decontamination using HEPA filtered air.
It is equipped with a ventilation system that provides filtered air to ensure a clean environment inside the chamber, before the opening of the door.
The system keeps the door blocked where the charge has been carried out, allowing the removal of the material from the other door; with the aim to not contaminate the clean area during the ventilation cycle.
Biological SAS
Equipment uniquely designed for the transfer of materials for biological neutralization of elements and bio-contaminated materials between classified areas or between a classified area and a non-classified area.
This is equipped with a bio-decontamination system by means of a hydrogen peroxide generator. (external or integrated which is optional).
The system keeps the door blocked where the charge has been carried out, permitting the removal of the material from the other door; with the aim to not contaminate the clean area during the ventilation/disinfection cycle.
