Specialist Containment Solutions

ONFAB Limited. 1 Verity Court, Middlewich, Cheshire, CW10 0GW. UK

T: +44 (0)1606 832 080

F: +44 (0)1606 835 435

www.onfab.co.uk

A message from our CEO’sWhen we set up ONFAB Limited our aim was to create a design and supply company that match the values we expect and appreciate as a customer. These values are honesty, reliability, quality and value for money. These values have been the foundation that ONFAB can attribute to ten years of success and business growth. We are proud to be able to say that we have the same customers that we started with, and that the majority of our business comes from customer referral within a highly regulated and demanding industry.

Global Leader in Containment TechnologiesSince the company was founded in 2004, ONFAB has developed an unrivalled expertise in the design and manufacture of flexible containment systems and technologyThe development and use of the equipment selection process model combined with unique product innovations has taken the capability of containment technology to new levels of performance, securing ONFAB as a global presence in the field of containment.

ONFAB Limited PartnersONFAB have partnered with a team of experts who work to ensure that all technical, material and site specifications are carefully considered and accounted for.

Quality & ExcellenceONFAB maintains a level of high quality design and manufacturing excellence, meeting the requirements of ISO 9001, the internationally recognised standard for an organisation’s internal quality management.

Industry Recognised ExpertsWith a wealth of experience in the containment industry we understand all of the critical factors that must be taken into account when evaluating a containment requirement and providing the best possible solution.

We will advise on protecting your work force, streamlining the manufacturing process, maximising floor space within a new or existing facility and generating flow strategies for personnel and materials.

Use our expertise to validate a new facility, generate detailed equipment / facility specifications and designs, project manage an installation or validate and test completed facilities.

Cost EffectiveOur priority is to provide you with the right solution, not the most expensive. This is why many of our customers make considerable cost savings when commissioning ONFAB to address their containment requirements.

Outstanding ServiceSetting up a new facility or modifying an existing one must be executed within the shortest possible time frames to minimise costs and loss of productivity. We work with you to meet the most challenging of schedules through every stage of the process from design to installation, ensuring a fast and efficient service.

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Holistic solution allowing autonomy of control

Proven engineering practices

Excellent customer service

Short lead times

Competitive prices

Why Use Onfab?

ONFAB Limited manufactures a wide range of products from flexible plastics such as Polyethylene, PVC and polyurethane film.

We have in-house technical and design skills to support product development, and can manufacture to customer specifications. We are able to provide short lead times, competitive prices with quality guaranteed to ISO 9001 standards.

ONFAB Limited’s flexible containment systems are world class and operate in various countries worldwide. We work daily with Key flagship pharmaceutical companies removing the requirements for expensive and space consuming hard walled isolators.

For many years the company has been at the forefront of technology, designing and manufacturing Flexible containment systems for the safe handling of potent Pharmaceutical ingredients and developing techniques to achieve levels of containment below 1μ/m³ in compliance with SMEPAC guidelines.

Containment Systems

Our products are made to the highest specifications by heat and high frequency electronic welding and computerized cutting systems, designing and developing intricate tooling when required.

We are ISO 9001 ISOQAR approved. This is the internationally recognised standard for the quality management of businesses, meaning we have been acknowledged as being capable of providing all of our customers with a high level of service and quality.

Quality

IsolationThe separation of a material or substance so that it does not come into contact with operators or the environment.

ContainmentThe enclosure of a material or substance so that operations/activities can take place without it coming into contact with operators or the environment.

Containment equipment / Barrier IsolationAn engineered unit that provides separation between a material or substance so that operations/activities can take place with out it coming in to contact with operators or the environment.

Containment Fundamentals

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Dust release levels. μg/m3

Open pouring 10,000

Valve on IBC 1,000

IBC and inflatable seal 500

Down flow booth (DFB) 50-100

DFB + screen 1 – 25

Split Butterfly Valve (SBV) 5 – 10

Flexible glove bags Ambient Pressure 1 – 10

Flexible glove bags Negative pressure 0.1 – 1

DFB and Flexible glove curtain 0.1 – 5

High Containment SBV 0.5 – 1

Alpha-beta port 0.1 – 1

Isolator and Rapid Transfer Port (RTP) 0.001

Monitoring campaigns vary from study to study.

The ONFAB Containment Philosophy Model Typical Equipment

Containment Performance The ONFAB Containment Philosophy Model

Scope and Standards

General Principalsand Guidelines

Activity Analysis

EquipmentSelection

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1 − Site measurement 2 − Preliminary design

3 − Final design 4 − Cut file produced upon order

Design Stages Preliminary design

Site measurement Specification

discussed with customer

Drawings or pictures sent with basic

specification

Preliminary design completed

Modifications made to design according to customer comments

Design approved by customer

Cut file produced upon order of new

products

The final design allows for any modifications to be made to the design for example:

■ Additional sleeves added

■ Dimensions finalised

■ Additional views drawn if required

■ 3D model rendered when required

Final Design

■ Produced from drawing / pictures or site measurements■ Designed to meet the required specification■ Often a very basic design to allow for a preliminary quote to be calculated within a very short lead time

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ONFAB can develop a more permanent solution to your containment needs if required with Perspex and stainless steel range

Features and Benefits

■ Increased containment performance■Elegant bespoke designs

■ Cost effective

■Simple ease of use

Rigid Isolators

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Vaporized Hydrogen Peroxide System (VHPS)

ONFAB now also offer Vaporized Hydrogen Peroxide Systems (VHPS®) and are operating exclusively in the UK as official agents to Tailin. This bio-decontamination technology offers the highest level of sterilisation across a broad spectrum including bacteria, viruses and fungi and is compatible with almost all materials, such as apparatus, computers, ceilings and floors.

It is safe and clean, leaving no residue, and is a highly effective and efficient sterilization method.

The VHPS® technology works by using a hydrogen peroxide generator to vaporise a 35% hydrogen peroxide solution and then transport it, either through pipelines or spraying directly in the enclosed spaces for bio-decontamination.

In the process of evaporation, the H2O2 will generate free hydroxyl, which could damage the cell composition (such as lipid, protein and DNA) by oxidation.

Vaporised hydrogen peroxide, under room temperature, has the ability to kill bacteria, fungi, viruses and other kinds of micro-organisms.

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ClaSP Liner Tie System

ONFAB Limited have developed a Liner Tie System, that combines ease of operation and high containment for the safe separation of glove bag feed sleeves and continuous liner material charge, discharge and storage.

Features and Benefits

■ Simple to apply■ High containment capability■ Great strength and durability■ Long term sealing■ Double lock security preventing accidental release■ Anti tamper and locking capability■ Can be used across all the linear and sleeve ranges

The ClaSP system demonstrates performance of less than10μg\m operator exposure levels when tested using the ISPE Guidelines for the Testing of Containment Equipment

Patents Pending: 0813067.6 and 0718403.9

Vaporized Hydrogen Peroxide System (VHPS)

The feature of VHPS® technology is that vapour hydrogen peroxide in the enclosed spaced isolator is always below drip point in the decontamination process.

When reaching the designed concentration, it will always control the relative humidity of the space. This will avoid the moisture saturation so as to reduce the affection of condensation.

The main advantage of dry VHPS® technology is that it minimises the impact on materials while achieving the highest level of decontamination. What’s more, it optimizes the time of H2O2 residue removal.

Key benefits: VHPS provides unique technology in hydrogen peroxide decontamination and isolator system.

Broad spectrum sterilisation including bacteria, viruses, fungi and other types of micro-organisms.

Provides complete sterile, detect and verification solutions for customers.

Minimum impact on materials, no H2O2 condensation and adherence.

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API and Development Facilities (Pilot Plant)

Pressure filter discharging (Site pressure test)

Reactor charging Containment suites

Product Range

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Reactors

Charging

Sampling

Remote charging suite

Drum Transfer

Pressure filters

Discharge liner systems

Discharge glove bags

Sampling

Discharge valve cleaning

Heel recovery glove bags

Vacuum drying de-duster containment suites

Containment suites

Filters

Safe Change

Gaff filter safe change systems

Core change out systems

CentrifugesCharge systems

Discharge systems

Flow booths Flow booth curtains

API and Development Facilities (Pilot Plant)

Small and Medium Scale Manufacture. (Phase One and Two)

Fluid bed dryer

Tablet press Blister packing room

Capsule filler

Product Range

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Dispensing Dispensing glove bags

Granulators (All manufactures 1ltr to 40ltr scale)

Charging

Sampling

Discharging

Material transfer Equipment contained connect and disconnect systems

Fluid bed dryers(All manufactures 1ltr to 40ltr scale)

Charging

Sampling

Discharging

Blenders(All manufactures 1ltr to 40ltr scale)

Charging

Sampling

Discharging

Tablet presses Bespoke designs

Tablet coaters Bespoke designs

Capsule fillers Bespoke designs

De-dusters Bespoke designs

Small to Medium Scale Manufacture. (Phase 1 & 2)

Product range

Kilo Laboratories

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Reactors

Charging

Sampling

Discharging

Flow booths Flow booths curtains

Dispensing Dispensing glove bags

Flow booth curtains Flow booth curtains

Product range

Packing Lines & Dispensing

Tablet and blister packing linesSpecifically designed

enclosures

Liner dispenserFully disposable and stainless

steel options

Discharge

Fully disposable liner dispenser Stainless steel inline liner carrier/dispenser

Support Products

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Gloves Fan Set

Support System CHEM Tape

Filters Bungee Cord

Installation Kit ClaSP System

U Grip Stretch Tape

HEPA Filter High Bond Tape

O Rings Filter Connections

Cuffs Drum

Flexible Canister Safety Scissors

Many more product available.

Support Products

ONFAB Limited. 1 Verity Court, Middlewich, Cheshire, CW10 0GW. UKT: +44 (0)1606 832 080F: +44 (0)1606 835 435

www.onfab.co.uk

Global containment supplier:

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