Automatic Certified Quality sealing Products process for unmatched sealing consistency

Transcription

1 4s3 Solutions Semi-Automatic for Molecular Sheet Diagnostics Heat Sealer Automatic Certified Quality sealing Products process for unmatched sealing consistency FOR MOLECULAR DIAGNOSTICS Off-the-shelf and Custom Solutions for Manufacturing Diagnostic Kits ISO 9001 and ISO production in class 7 cleanrooms Certified, state-of-the-art manufacturing for medical devices Custom product design and manufacturing of injection moulded parts Smooth transition from idea to product Modular plate and sealing solutions available off-the-shelf Quick and easy kit construction 4titude Ltd. The North Barn Surrey Hills Business Park Damphurst Lane Wotton Surrey RH5 6QT T: +44 (0) F: +44 (0) E: info@4ti.co.uk

2 Solutions for molecular diagnostics 4titude provides off-the-shelf and custom made consumables for molecular diagnostic kit manufacturing. We design and produce innovative solutions which address the needs of kit manufacturers and end users at the same time. Our automation friendly consumables can be handled robotically at the manufacturers site and later be divided into smaller sections to suit the end users needs. 96 well and other plate formats for different applications including PCR Custom formats available on request Plates can be divided into smaller plate sections, e.g. 8-strips & single tubes 2D coding, barcoding and colour coding for tracking of samples Variety of sealing options for safe storage and shipping Meeting the demands of manufacturers & end users

3 4titude manufacturing & quality standards 4titude are ISO 9001:2008 & ISO 13485:2012 certified to manufacture and supply consumables for the life sciences sector. Our management systems comply with the requirements to produce medical devices which we sell to diagnostics companies of all sizes including multinational corporations. We also provide complete custom design solutions from prototyping to tool design and contract manufacturing. Manufacturing standard ISO 9001:2008 & ISO 13485:2012 certified Process validation & mapping Fully document controlled manufacturing processes Statistical analysis of production processes Continuous improvement programs Injection moulding in ISO class 7 cleanrooms Virgin, medical grade polymers Quality standard 4titude performs visual, physical and biological tests to ensure that our consumables are contamination free, as well as verify the integrity of the products at all times. Consumables are certified free from bacterial and human genomic DNA, nucleases and pyrogens Skirted micro- and PCR plates meet the SBS standard footprint PCR inhibition tests are performed on all polymers used Leak tests are performed on every well of every PCR plate White-well plates are checked for low background fluorescence

4 FrameStar Break-A-Way - Division brings flexibility! The 4titude Break-A-Way plate range offers all the advantages of our popular FrameStar 2-component products in a format that can easily be divided into segments, strips or even individual tubes. This product range enables reagent dispensing to be automated in plate format, then post-dispensing the plate can be divided, as required, by either the manufacturer or the end-user. Dividable horizontally, vertically or both 0.1 or 0.2 ml tube volume options A choice of frame colours available Clear or white wells 2D coding offered Sterilisation options Also available as pre-cut strips, FrameStrips Sealable with cap strips, adhesive or heat seals Plate segmentation can be automated FrameStar Break-A-Way plates FrameStar Break-2-Ways, dividable both horizontally and vertically FrameStrip 2D coded Vari-Plates - Holding it together! The 4titude Vari-Strip and Vari-Plate system offers total flexibility in plate usage. It allows the user to insert or remove strips of 8 tubes from a 96 well plate frame. Choice of frame styles to suit most instruments Clear or white well strips Pre-loaded frames Sealable using strip caps, adhesives or heat seals 0.1 ml tube volume Vari-Strips with white tubes for highest sensitivity Non-Skirted PCR Plates - More than just standard! The thin-walled tubes of our standard 96 well PCR Plate maximise heat transfer and the raised tube rims facilitate sealing. Available as segments of 8, 16, 24, 32 and 48 wells 6 colour options available White version for optical applications Available freely dividable into sections or strips (Tear-A-Way PCR Plate) Sterilisation options Sealable with strip caps, adhesive or heat seals Non-Skirted PCR Plate Segments Available in clear, purple, red, blue, green, yellow and white with black alpha-numeric lettering 96 Well Non-Skirted PCR Plate also available as Tear-A-Way version, dividable in 8 strip or 12 strip direction

5 Random Access Plates - Individually removable wells! Random Access (RA) plates provide the greatest flexibility in PCR plates, affording handling of individual wells in a 96 well plate format. Rigid frame does not expand during PCR cycles allowing RA tubes to fit tightly in the frame before and after PCR PP wells low binding to nucleic acids and high solvent resistance, ideal for both PCR and storage Thin walled tubes optimal heat transfer during PCR Individually sealed using RA seals tubes can be filled, sealed and then Random Access 96 Well Skirted PCR Plate removed individually, see next page for details Tubes can be removed and inserted again ultimate flexibility Storage of small samples easily retrieval of small volumes Also available with flat bottomed, 2D coded tubes - the perfect storage solution Customisable with tubes with coloured rings or coloured tubes for improved sample identification Space saving - plates can be stacked to take up minimal freezer space Random Access 96 Well Skirted Flat Bottom PCR Plate, 2D Coded Customisable with tubes with coloured rings Customisable with coloured tubes Plate Cutter - Split it your way! The plate cutter can be used to divide a plate, whether sealed with caps, adhesives, heat seals or unsealed. Plates can be divided into any format as required: segments, strips or individual tubes. With heat or adhesive sealed plates the plate cutter can also be set to divide the seal only, without damaging the plate itself. Semi-automated Simple division of Break-A-Way and Tear-A-Way plates Available in 8 or 12 strip format Separates plates into segments, strips or single tubes Suitable for division of seals applied to PCR style plates Compatible with plates sealed with caps, adhesive or heat seals I. Place the plate (e.g. Vari-Plate ) on the shuttle, close the shuttle II. The plate/seal is cut into segments III. Remove the cut plate from the device

6 Heat Sealing - The ultimate bond! With 4titude Heat Sealing systems, samples can be sealed for evaporationfree heating (including PCR), secure storage and shipping. Instrumentation and compatible sealing materials are available from stock but bespoke heat sealers, seal formats and materials can also be designed and manufactured on request. Our unique InterSeal system combines heat sealing with adhesive sealing for the ultimate solution for secure reagent transport and flexibility of end user handling. Please refer to the next page to see a typical application of the InterSeal. Catalogue and custom Heat Sealers Robotic integration compatible Peelable and piercable options Optical and gas permeable options Rolls, sheets or custom seal formats a4s Automatic Roll Heat Sealer Thermal transfer printing available Automation of seal division and removal available InterSeal double sided adhesive film 4s3 Semi-Automatic Heat Sealer Custom heat sealer Custom printed seal Random Access Heat Sealing - Individually Sealed Tubes! Random Access plate formats can be sealed in one go to give individually accessible, sealed tubes with no further processing required. Seals can be pierced, allowing for sample access when required. Random Access Heat Seals - 96 individual foil seal spots on a removable backing - are available in sheet format for use with the 4s3 Semi-Automatic Sheet Heat Sealer in combination with a Random Access adaptor. The roll-fed a4s RA Automatic Random Access Heat Sealer allows for automatic sealing of Random Access plates using Random Access Heat Seal rolls carrying indexed groups of 96 individual sealing discs. a4s RA Automatic Random Access Heat Sealer Manual Random Access Heat Sealing using the 4s3 Heat Sealer Individually sealed Random Access Tubes

7 A typical workflow At the kit manufacturer I. Vari-Plate loaded with Vari-Strips can be filled with reagents on a robotic system II. Heat sealing with 4s3 Semi-Automatic Heat Sealer III. Vari-Plate sealed with pierceable seal IV. Apply adhesive InterSeal to the plate V. Cut seals with the 4titude Plate Cutter VI. Remove strips from the Vari-Plate. Pre-filled strips ready for diagnostics. At the point of diagnostic use VII. Remove InterSeal protective layer VIII. Pierce the foil and add the sample to the strip pre-filled with reagents IX. Reseal strips with foil X. Ready for PCR analysis! The Vari-Plates allow for 8 well strips to be processed like a 96 well plate on robotic systems while the end product is in flexible 8 well format. Sealing the plates with a heat seal results in lowest evaporation and best possible long-term storage. With the use of a pierceable seal, samples can easily be added at the point of diagnostic use. The protective InterSeal makes sure there will be no damage to the seal during transportation. After removal of the InterSeal protective layer, samples are added and the strips are resealed for subsequent PCR analysis. In this workflow the 4titude Plate Cutter only needs to cut the seals, it could also cut seals and plates if FrameStar Break-A-Way PCR Plates were used instead of the 8 well Vari-Strips in Vari-Plates.

8 Real-Life Case Study 1 Customer: A company producing a human diagnostic kit for the detection of infectious disease. Kit manufacturing requirements: Kit components need to be dispensed into PCR plates to produce an IVD/FDA approved kit subject to the highest quality standards. Requirements of the final product: The kit is for use on an automated diagnostic instrument, automation of plate handling, liquid dispensing and sealing is required. Key issues to be solved Automated handling: Automated plate handling and liquid dispensing requires the use of a rigid automation compatible qpcr plate Heat Sealing: The use of highly infectious agents requires a secure plate sealing method which can be integrated into an automation system 4titude products used Code Description 4ti-0951/SBC FrameStar 96 Well Semi-Skirted PCR Plate, Roche Style, Single Barcoded 4ti-0665 a4s Automatic Roll Heat Sealer 4ti-0573 Clear Weld Heat Seal Mark 2 qpcr Analysis: A transparent, permanent seal is needed suitable for qpcr analysis Processes of the workflow AUTOMATION FRIENDLY 1. The reagents are dispensed in the FrameStar 96 Well Semi-Skirted PCR Plate, Roche Style using a liquid handling robot. The 2-component construction of FrameStar plates is ideal for automated handling. This plate does not warp following amplification or heat sealing, enabling accurate automated plate handling and liquid dispensing. SAMPLE TRACKING 2. The plate is barcoded on one side to enable sample tracking throughout the workflow. Barcodes can be applied on any side of a plate and any 10 digit specification can be used, enabling true efficiency of sample tracking. SEALING SOLUTIONS 3. The a4s Automatic Roll Heat Sealer is integrated within, and controlled by, the customer's automated system and is used to apply Clear Weld Heat Seal Mark 2 to each plate. Up to 5000 seals can be applied consistently without intervention using this set up and the seal applied provides a 100% leak proof seal for secure handling of infectious material. OPTIMISED FOR QPCR 4. The plate is placed on a Roche LightCycler for qpcr analysis. The white wells of the plate ensure no well to well signal contamination occurs, the clear seal is optically clear for maximum signal detection. 1./ FrameStar Plate Filling with reagents Heat Sealing qpcr analysis Fully Automated Liquid Handling Robot Integrated a4s Heat Sealer Roche LightCycler

9 Real-Life Case Study 2 Customer: A healthcare company in Germany Kit manufacturing requirements: Our customer manufactures a number of kits for human diagnostics. Requirements of the final product: Typically, the kits are utilised at the point-of-care by commercial laboratories for a varying number of patients per day. These laboratories need to use kits on a large variety of standard thermal cyclers. Key issues to be solved Suitable PCR plate: A standard non-skirted PCR plate format is required for flexible use in consumer laboratories on a variety of thermal cyclers. The end user laboratories handle varying numbers of patient samples and do not wish to utilise a full 96 well plate. Shelf life: A long shelf life is necessary to enable shipment of the kits around the world and to suit the end user. 4titude products used Code 4ti-0750/8 4ti-0750/16 4ti-0750/24 4ti-0750/32 4ti-0750/48 4ti-0752 Description 1 x 8 well plate segments 2 x 8 well plate segments 3 x 8 well plate segments 4 x 8 well plate segments 6 x 8 well plate segments Strips of 8 Domed Caps Product identification: Each kit type must be easily identifiable during manufacturing Processes of the workflow 1. 4ti-0750/# plate segments are filled with reagents using a semi-automated liquid handler. A number of segments can be placed next to each other in each 96 well plate holder for maximum efficiency. 2. 4ti-0752 cap strips are used to seal the segments for secure shipping to the customer. Cap strips ensure a secure leak proof seal for shipping and storage. 3. The customer adds a DNA sample and then reseals the strip with the previously removed cap strips for PCR analysis. 4. The customer removes the cap strips following PCR and removes the PCR product for downstream analysis.

10 Ordering information - Make your choice! Code Name and description Instrumentation our catalogue instrumentation, custom units are available on request 4ti ti ti ti ti ti s3 Semi-Automatic Sheet Heat Sealer; unique and cost saving adaptor system for highest flexibility a4s Automatic Roll Heat Sealer a4s RA Automatic Random Access Heat Sealer Plate Cutter; standard and custom cutter heads are available Barcode Rack Scanner; for reading 2D coded racked tubes Hand Held Barcode Scanner; can read any linear barcode or 2D code Plates Tear-A-Way Plates 4ti-0750/TA Tear-A-Way 96/8 PCR Plate, 96 well non-skirted PCR plate, vertically perforated, tears easily into strips of 8 tubes or part plates, standard profile, 0.2 ml wells, clear PP, cut corner H12; also available in white 4ti-0750/TA/12 Tear-A-Way 96/12 PCR Plate, 96 well non-skirted PCR plate, horizontally perforated, tears easily into strips of 12 tubes or part plates, standard profile, 0.2 ml wells, clear PP, cut corner H12 FrameStar Break-A-Way Plates (7 frame colours available) 4ti ti ti ti ti-1300/X FrameStar Break-A-Way PCR Plate, 96 well semi-skirted plate, vertically scored, snaps easily into strips of 8 tubes or part plates, standard profile, 0.2 ml clear PP wells, clear PC frame, cut corner A12 FrameStar Break-A-Way PCR Plate, 96 well semi-skirted plate, vertically scored, snaps easily into strips of 8 tubes or part plates, standard profile, 0.2 ml white PP wells, black PC frame, cut corner A12 FrameStar Break-A-Way PCR Plate, Low Profile, 96 well semi-skirted plate, vertically scored, snaps easily into strips of 8 tubes or part plates, low profile, 0.1 ml clear PP wells, clear PC frame, cut corner A12, FrameStar Break-A-Way PCR Plate, Low Profile, 96 well semi-skirted plate, vertically scored, snaps easily into strips of 8 tubes or part plates, low profile, 0.1 ml white PP wells, black PC frame, cut corner A12 FrameStar Break-2-Ways PCR Plate, 96 well rigid plate, vertically and horizontally scored, snaps easily into part plates, 8 well strips, 12 well strips, part strips or individual tubes, standard profile, 0.2 ml clear PP wells, black PC frame Plate segments (6 colours available) 4ti-0750/8 4ti-0750/16 4ti-0750/24 4ti-0750/32 4ti-0750/48 8 Well Non-Skirted PCR Plate Segment, 1 x 8 wells per segment, standard profile, 0.2 ml wells, clear PP 16 Well Non-Skirted PCR Plate Segment, 2 x 8 wells per segment, standard profile, 0.2 ml wells, clear PP 24 Well Non-Skirted PCR Plate Segment, 3 x 8 wells per segment, standard profile, 0.2 ml wells, clear PP 32 Well Non-Skirted PCR Plate Segment, 4 x 8 wells per segment, standard profile, 0.2 ml wells, clear PP 48 Well Non-Skirted PCR Plate Segment, 6 x 8 wells per segment, standard profile, 0.2 ml wells, clear PP Vari-Strips and Vari-Plates 4ti-0753/757 4ti-0753/C/757 4ti-0757-F 4ti-0753/950W 4ti-0950W-F 4ti ti-0753/C 4ti ti-0754/C Vari-Plate 96 Well Skirted Frame, With Vari-Strips, 96 well skirted frame, white, pre-loaded with Vari-Strip 8 well PCR tube strips, low profile, 0.1 ml wells, white PP As above, with clear PP strips Vari-Plate 96 Well Skirted Frame, 96 well skirted frame, white, for use with Vari-Strip 8 well PCR tube strips Vari-Plate 96 Well Semi-Skirted Frame, Roche Style, With Vari-Strips, 96 well semi-skirted frame, white, pre-loaded with Vari-Strip 8 well PCR tube strips, low profile, 0.1 ml wells, white PP, designed for use on Roche LightCycler 480 Vari-Plate 96 Well Semi-Skirted Frame, Roche Style, 96 well semi-skirted frame, white, for use with Vari-Strip 8 well PCR tube strips, designed for use on Roche LightCycler 480 Vari-Strip 8 Well PCR Tube Strips, Low Profile, low profile, 0.1 ml wells, white PP As above, with clear PP strips 4ti-0753 plus strips of 8 flat optical caps, combi pack 4ti-0753/C plus strips of 8 flat optical caps, combi pack

11 Random Access Plates 4ti-0960/RA 4ti-0960/RA-F Random Access 96 Well Skirted PCR Plate, 96 individual tubes in plate format, low profile, 0.1 ml clear PP tubes, white PC frame, cut corner H1 Random Access 96 Well Skirted Frame, 96 well skirted frame, white PC, rigid skirt, cut corner H1 Sealing solutions - A selection from our vast range of heat seals and adhesive seals Heat seals 4ti ti ti-0531/GR 4ti ti ti ti-0575/FS 4ti-05381/RA Peel Heat Seal, peelable heat sealing foil, suitable for low temperature storage/high temperature uses/pcr, sheets; also available in roll format Pierce Heat Seal, pierceable heat sealing foil, high solvent resistance, resealable, suitable for PCR/storage/ shipping, sheets; also available in roll format Pierce Heat Seal, With Grid Reference, pierceable heat sealing foil, with printed grid reference, high solvent resistance, resealable, suitable for PCR/storage/shipping, sheets Clear Heat Seal, peelable heat sealing film, optically clear, suitable for qpcr/optical applications, sheets; also available in roll format DMSO Resistant Peel Heat Seal, solvent resistant heat sealing foil, peelable, suitable for low and room temperature compound storage, sheets; also available in roll format 96 INDI Heat Seal, 96 perforated individual sealing caps in a foil frame, peelable, pierceable, suitable for low temperature storage, sheets Clear Weld Heat Seal Mark 2 FrameSeal, optically clear heat sealing film, non-peelable, difficult to pierce, suitable for qpcr/optical applications/storage, stackable frames; also available in sheet and roll format Random Access Pierce Heat Seal Strong, strong heat sealing foil, 96 individual seals in sheet format, pierceable, suitable for PCR/sample shipping/compound storage, sheets; also available in roll format Adhesive seals 4ti ti ti ti-0516/24* (/96*, /384*) 4ti ti ti-0566* InterSeal, double sided adhesive film, black, with 96 holes and a protective liner, peelable, suitable for resealing without the need for a heat sealer, sheets PCR Seal, clear adhesive film, strong adhesive, peelable, suitable for PCR/optical applications, sheets; also available in two flexible formats with perforated sheets and as half plate seals DMSO Resistant Foil, Peelable adhesive foil, strong adhesive, high solvent resistance, suitable for long term storage, sheets Moisture Barrier Seal, gas permeable adhesive film, optically clear, with 24 (96, 384) adhesive free windows, peelable, pierceable, sterile, suitable for cell culture, sheets PCR Foil Seal, pierceable adhesive aluminium foil, strong adhesive, peelable, suitable for high temperature applications, sheets qpcr Seal, optically clear adhesive film, pressure activated adhesive, peelable, suitable for qpcr/optical applications, sheets Pierceable Film, Strong adhesive seal with cross-cut windows, peelable, pierceable, suitable for 96 well plates (auto samplers, HPLC, sequencers), sheets Processing options 4ti-####/SBC 2D coding Our 4titude single bar code can be applied to any plate with a skirt or semi-skirt. The standard barcode format is 8 digits with one letter (e.g. 4T123456), printed in Code 128 which is compatible with most barcode readers. In addition, human readable format is printed to the right of the label, ensuring samples can always be identified. Also available: Double barcode /DBC, triple barcode /TPC or quadruple barcode /QBC We are able to custom 2D code a number of our products, such as the base of our cluster tubes or the caps of our PCR tubes. Please enquire. Custom barcoding Our custom barcoding service can add a barcode of your choice in the position of your choice. Sterilisation Custom packaging A number of our products are available sterile from stock. We can also offer custom sterilisation by gamma irradiation or ethylene oxide treatment, please enquire. We can provide a number of custom packaging services. These include specified bagging quantities, custom labels and white box packing. Please enquire. * Not available for purchase in or onwards distribution to the USA

12 License Statement & Trademarks Disclaimer: FrameStar FrameStrip, Tear-A-Way, Vari-Plate, Vari-Strips and 4s3 are registered trademarks of 4titude Limited; LightCycler is a registered trademark of Hoffmann-La Roche. Designated trademarks and brands not mentioned above are the property or their respectice owners. FrameStar PCR plates are covered by one or more of the following U.S.patents or their foreign counterparts, owned by Eppendorf AG: US Patent Nos. 7,347,977 and 6,340,589 Distributed by: Image credits: kras99/hywards - Fotolia.com 4ti-FL-0006 Brochure Consumables for MD en4/0/1/ OP 4titude Ltd. The North Barn Surrey Hills Business Park Damphurst Lane Wotton Surrey RH5 6QT T: +44 (0) F: +44 (0) E: info@4ti.co.uk