10300S Singapore Catalog

User Manual: 10300S

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Specimen Collecon

and Transport

Products Catalog

Featuring

An Introducon to

Global King Management:

• Client Supply Services

• Clinical Trial Services

therapaksg.com

2 Global Kitting Management

Client Supply Services

Serving hundreds of Personalized Medicine companies, Reference Laboratories, Hospital Outreach

Laboratories and Pathology Testing organizations, Therapak is the preferred supplier for kit development,

commercial launch and order management and tracking programs.

Kit Development

Therapak’s team of experienced professionals, armed with a broad

base of over 3,000 component products, will work closely with customers

to address every aspect of their kit supply needs and ensure timely

delivery of supplies to meet project launch timelines.

Production

Having produced over 100 million kits, Therapak is the Global Leader in regulated kit production across

all clinical and commercial disciplines. Our systems are designed to accommodate batch sizes as small

as a single clinical trial visit-specic kit to those as large as several thousand repetitive commercial kits.

Ordering

Therapak’s Client Supply Express (CSE) Online ordering software intelligently

manages the ordering process using Kit-Track ID technology to maintain full

visibility of the kit lifecycle. With over one million individual site orders

processed, CSE offers secure 24/7 global access to customer-specic

ordering menus that are user name and password protected.

Recycling

Therapak works closely with customers to implement recycle and reuse

programs. These initiatives target packaging components and supplies

that can be easily recovered, recycled and safely reused without the risk

of contamination.

Distribution

Therapak offers a globally harmonized kit production solution from four cGMP compliant and registered

facilities strategically located in Los Angeles, Atlanta, London and Singapore.

Printing

In addition to accommodating your kit supply needs, Therapak provides a

complete solution for your printing needs, including: preparation of customized

and branded Laboratory Requisition Forms and Booklets, on demand printing of

site-specic Requisition Forms and on demand printing of site-specic shipping

documents.

Quality Assurance

Therapak’s quality system operates in accordance to the United States Food and Drug Administration’s

current Good Manufacturing Practices for medical devices - 21 CFR § 820; Singapore HSA’s TS-01

- Good Distribution Practices for Medical Devices and Good Assembly Practices; and Article 12 of

Council Directive 93/42/EEC concerning medical devices.

Global Kitting Management

Clinical Trial Services

Therapak is the global leader for protocol-speciﬁc specimen collection/shipping kit manufacturing

and distribution. For over a decade, Therapak has been the supplier of choice for Central Labs,

CROs, Pharma and Biotech in the Clinical Trials market.

Project Management

• Account-specific Project Manager

• Proprietary Kit Production and Inventory Management System

Kit Assembly and Site Distribution

• Proven workflow processes to control production and packaging

• Order-driven integration of all site supplies and documents

• Procedural quality inspection in accordance with cGMP standards

Frozen and Biological Substance Specimen Transport

• Temperature sensitive shipping products

• Certified biological substance shipping system to UN3373 specifications

• Customization availability of ambient, refrigerated and frozen packages

Online Ordering

• Define new protocols and establish Investigator Sites

• Place protocol-specific supply orders using drop down menu options

• Obtain electronic order confirmation with hyperlinked shipment tracking data

Therapak’s online supply management portal called CT-Online gives sponsors and laboratories

secure web based access to:

Printing

• Customized requisition form and lab manual printing

• Laboratory and investigator manual assembly

• Barcode label development and printing for accessioning and storage

• Custom cryogenic tube label development for Early Phase, PD and PK studies

Therapak assists in the development and printing of your study requisition forms and labels customized

for your protocol needs and fully tracked to the investigator site with our Accession Track technology.

Quality Assurance

Therapak SG Pte. Ltd. is licensed by the Health Sciences Authority to import and distribute medical devices globally

and has been certiﬁed by a SAC-accredited third party as compliant to the HSA’s TS-01: Good Distribution Practice

for Medical Devices – Requirements for activities related to the import, storage, secondary assembly and distribution

of medical devices.

Therapak offers protocol-customized specimen collection and transport kits for all your specimen

collection needs, from routine safety to specialized biomarker, tissue and PK/PD collection kits.

4 Absorbents and Zip Style Bags

Absorbent sheets are the most cost-effective absorbent product that complies with the

regulations governing specimen transport. These tissue-based papers are impregnated with

super-absorbent polymers to absorb liquids that may escape during transport. Sheets can

be purchased in a variety of stock sizes or custom cut to meet your specic requirements.

Absorbent Sheets

• Uses super-absorbent polymers

• Complies with IATA regulations

• Available in a variety of sizes

10300S

Aqui-Pak™ was designed for the safe transport of laboratory specimen tubes by keeping the tubes separate and providing cushioning at

the same time. It consists of a multi-layered polymeric material that has extremely high absorption properties. To use, simply place the

tubes in the provided bays and insert the Aqui-Pak™ into secondary packaging. During shipment, Aqui-Pak™ is best used in combination

with a specimen bag or canister to comply with IATA shipping regulations.

• Ideal for Biological Substance Category B or

Exempt Animal/Human Specimen packaging

• Excellent absorbent capacity

• Can be customized to individual specifications

10316S

Absorbent Pouches

Zip Style Biohazard Transport Bags (Two-Pouch)

Reclosable Zip Style Bags are clear and printed with the biohazard symbol on the outside. The two-pouch bag is

manufactured to hold the specimen in one pouch and a requisition form in the other.

• Re-sealable

• Conveniently holds specimen and paperwork

• Available with biohazard symbol

95kPa Bags and Insulated Shippers

• Patented leak-resistant seal

• Convenient second pocket for paperwork

• Meets IATA requirements

95kPa Transport Bags for UN3373 Biological Substance Transport

Therapak’s two-pocket specimen bags are ideal to use as a secondary watertight receptacle in accordance

with IATA regulations for shipping Biological Substances. IATA shipping regulations require that UN3373

Biological Substance, Category B specimens are transported in either a primary container or secondary

packaging that has passed the 95kPa pressure differential test.

Therapak’s 95kPa certied bags feature a patented leak-resistant seal. Specimen tube(s) and absorbent

materials can be securely sealed within the front pocket of the bag by peeling away the white tape and folding

the adhesive down to cover the opening. The back pocket is typically used to hold a requisition form.

Insulated Shippers

• Ideal insulated shipper sizes for reference laboratories, pharmaceutical companies, hospitals and clinical testing laboratories

• Each shipper contains one outer corrugated carton, one corrugated insert and one EPS cooler

• Small and Medium size are packed in convenient four per case quantities

Choose from three popular sizes of Expanded Polystyrene (EPS) insulated shippers. These durable and protective packages offer internal

dimension capacities of 5.5 liters (Small), 17.5 liters (Medium) and 47 liters (Large). Applications for these shipping systems include

refrigerated and frozen specimen transport when combined with inner packaging such as gel refrigerant packs, cold bricks or dry ice.

Transport bags and absorbent materials are also sold separately.

Gel Refrigerant Packs

Gel Refrigerant Packs 0ºC are an economical alternative to wet ice commonly used as cold

packs in conjunction with insulated shippers for transporting laboratory specimens.

Enclosed in a durable 4.1 mil polyethylene lm, gel refrigerant packs provide reliable refrigeration

for safe transport without leaks or spills which would contaminate your product. Choose from

the various sizes in the ordering table below.

Therapak® Gel Refrigerant Packs

• Safe and cost effective

• Sturdy construction prevents leaks or spills

• A wide variety of sizes available

EverCold® Foam Bricks consist of an absorbent, rigid open cell foam brick and a special aqueous solution that freezes fast and maintains

a long lasting cold. Tough, durable recyclable polyethylene wrappers with heat-welded seams ensure maximum resistance to punctures,

tears and splitting. EverCold® Foam features a consistent, uniform structure and a non-toxic, non-caustic composition. Brick shape is

ideal for lining square and rectangular shipping containers.

EverCold® Foam Refrigerant Bricks

• Open-cell brick freezes fast

• Reusable, non-toxic, non-caustic composition

• Heat-welded seams resist splitting

The gel wrap has been used as a wrap-around barrier to insulate valuable samples such as clinical trial specimen tubes or other evacuated

blood tubes and serum transport vials. No preconditioning is necessary due to the gelatin type mass that is concealed inside the outer

polyethylene lm producing an insulating layer of protection between extreme external temperatures and the specimen transport bag

holding the specimen tubes. To use, lay the gel wrap on a at surface and place your transport bag containing the specimen tubes and

absorbent material on one half of the gel wrap. Fold the other half of the gel wrap on top of the tubes and place into a suitable insulated

shipping container. The gel wrap can be used in conjunction with the Therapak® Insulated Envelope (56424S) by inserting the gel wrap

into the envelope and placing the envelope into a shipping box for transport.

Therapak® Ambient Gel Wrap

• Elongated construction wraps around standard specimen transport bags

• Ideal barrier to protect ambient specimens during transport

• Adaptable component for inclusion in biological sample shipping systems

Mailers and Shippers 7

Therapak’s Insulated Envelope offers sanitary protection of samples transported in specimen bags. The reusable mailer

can also be used in conjunction with the Therapak® Ambient Gel Wrap (56422S) to form an insulating package for the

transport of biological samples inside of a transport bag. The sample bag with tubes and absorbent is concealed in an

insulating barrier of gelatin-like protection.

Therapak® Insulated Envelope

• Triple layer construction maintains integrity of samples

• Reusable envelope features leak-resistant zipper seal

• Combine with Ambient Gel Wrap for best ambient shipping results

Duramark® Variable Temperature Shippers

This temperature transport system provides a cost-effective method for

shipping samples collected at the clinic, hospital, or physician to a testing

laboratory. The system offers variable temperature compartments within

one shipping overwrap container. The overwrap container consists of a 4 mm rigid corrugated plastic container (36520S) that is reusable.

Up to four (4) standard congurations are available. Frozen, refrigerated and room temperature specimens can be shipped safely and

efciently in one package. The overwrap container comes with easy-to-carry handle and features strapless closure system.

36520S

• Multiple temperature capability

• Custom print and material colors available

• Reusable

Choose your internal conﬁguration to ﬁt your variable temperature needs.

a.) 36520S + 36519S. b.) 36520S + 36518S + 2 x 36517S.

c.) 36520S + 2 x 36518S. d.) 36520S + 4 x 36517S.

These ambient shipping boxes are ideal for kit packaging and outbound shipping of diagnostic kits. Each box has a specic tab-lock

mechanism to keep boxes closed during transport. Known as two-way shipper boxes, all ambient shipper boxes can be used for return

transport to the laboratory in addition to outbound shipping.

Custom kit boxes can be printed with a company logo by Therapak’s in-house graphics department. Minimum orders range from 1000

boxes to 2500 boxes, depending on what size box you require.

Boxes

• Meets IATA Packing Instruction 650 dimensional requirements

• Ideal kit packing boxes for reference labs, clinical trials and pathology kits

• Various sizes to choose from based on kit contents and sample load

Safety and Tube Racks

Spill Kits include protective outerwear, bags and

biohazard containment/cleanup supplies.

Standard Biohazard Spill Clean-up Kit (30167S)

1 full-length impervious open-back gown

1 pair powder-free hypoallergenic 305 mm latex medical gloves

1 uidshield procedure mask w/splashguard visor

1 pair impervious high-top shoe covers

1 body uid treatment/encapsulant (BTE)

1 pair disposable waste scoops

1 surface disinfectant wipe (XL)

1 antimicrobial hand wipe

1 biohazard waste bag

1 black waste bag

1 instruction sheet/incident report form

Mini Biohazard Spill Clean-up Kit (30168S)

1 pair powder-free hypoallergenic 305 mm latex medical gloves

1 body uid treatment/encapsulant (BTE)

1 pair disposable waste scoops

1 surface disinfectant wipe (XL)

1 antimicrobial hand wipe

1 biohazard waste bag

1 instruction sheet/incident report form

Chemotherapy Biohazard Spill Clean-up Kit (30166S)

1 pair High-Risk medical exam gloves

1 pair latex medical gloves

1 open back gown

2 absorbent towels

1 pair impervious high-top shoe covers

1 uidshield procedure mask w/splashguard visor

1 absoraide pouch

1 pair disposable waste scoops

1 surface disinfectant wipe (XL)

2 antimicrobial wipes

1 yellow chemo waste bag

1 yellow chemo bag

1 instruction sheet/incident report form

Biohazard Spill Kits

The TearTech® 25-hole foam rack is a versatile tube transport system that provides cushioning and protection for blood tubes, urinalysis

tubes and many other commonly transported test tubes. The die-cut construction allows users to tear away any number of tube holes

for transporting from 1 to 25 tubes. Combine with Therapak ambient kit boxes, insulated shippers, specimen bags and absorbent material

to complete specimen shipping requirements. Available in case quantities with or without specimen bag and absorbent for direct placement

into common insulated shippers. Block size: 150 x 150 x 100 mm.

TearTech® 25-Hole Foam Rack

• Accommodates standard tube sizes from 13 x 75 mm to 16 x 100 mm

• Die-cut construction permits tearing away variable grid sizes from 1 to 25

• Combine with boxes, insulated shippers and bags for specimen transport

68825S

Constructed of sturdy paperboard, Therapak disposable racks are shipped at and assembled

in seconds to reduce freight costs and decrease storage space. Tubes remain securely in place

during processing and transport for protection and identication. Both the Half Rack (127 x 114 x 64

mm) and Full Rack (242 x 114 x 64 mm) are printed with a numerical sequence for easy reference.

Disposable Tube Racks

• Fast assembly

• Safeguards tubes in transit

• Numerical reference

68928S

68929S

Shipping Systems 9

2-8°C Specimen Shipping System

Activation Instructions as easy as 1-2-3!

To use:

1. Open the box, remove the cooler and place it foil side down.

2. Push straight down (see image below) on the button and within 20 seconds the

cooling will begin.

3. Place your inner packaging with sample tubes in the chamber, put the cooler back

in its original position, close the box, and ship to the designated laboratory by

attaching completed air waybill.

Therapak’s 2-8°C Specimen Shipping System features a self-cooling

system built into the lid. With no refrigeration required, simply activate

the cooling process with the push of a button and your contents will

remain in the 2° to 8°C range for up to 48 hours with no further

conditioning or temperature control necessary. With no freezers

or refrigerators needed, no freezing of cold packs required, and less

packaging being shipped, the system saves you time, money, energy

and space.

This system provides a new way of shipping sensitive biological samples.

The NanoCool technology involves the transfer of heat from the inside

of the cooler to the outside by evaporating a small amount of water at

low pressure. Evaporation under such conditions takes place at low

temperatures and creates a cooling effect seven times more powerful

than ice packs. The active cooling process adjusts to varying ambient

temperatures in a way that conventional cooling systems cannot. This

completely portable shipping system comes ready to activate and

can be stored at room temperature.

• NanoCool arrives ready to activate and ship

• Completely portable

• No need to order, freeze or condition gel packs or worry about positioning

• Can be stored at room temperature

56849S

Labels

In accordance with current IATA Chapter 17 revised regulations for temperature sensitive products,

this package marking label is in the process of adoption under guidance by the TTTF (IATA - Time &

Temperature Sensitive Task Force). In an effort to develop minimum standards for the air transport

and handling of time and temperature sensitive products, it is the responsibility of the shipper to

apply the time and temperature sensitive product label to the outer packaging visible to package

handlers. The marking label must be afxed to at least one side panel of each individual package.

The lower half of the label may be used to indicate the transport temperature (allowable temperature

range) in Celsius designation and in English. If you do not know the transport temperature range, the

lower half of the label should be left blank.

Time and Temperature Sensitive label

544657S

Depending on the type of packaging selected to transport Biological Specimens, there are mandatory markings that must appear on the

outer packaging according to IATA regulations. Please refer to IATA Packing Instruction 650 for details. Please consult your Therapak

representative if you have any questions about the required markings.

Shipping and Compliance Labels

54530S

54752S

54782S

54635S

54607S

Labels shown approximately 50% scale.

Specimen Collection 11

Specimen Collection, Transport and Storage Containers

These containers are specically designed for secure collection and transportation of biological specimens for laboratory evaluation.

The container features accurate, easy-to-read, molded-in graduations on three sides. Top and bottom ribbed etchings ease the opening

and closing process when wearing examination gloves. Containers are exible, crack-resistant and are manufactured from virgin,

high clarity, chemically inert, medical grade polypropylene. Heavy duty polyethylene screw caps feature a unique dual ll circle thread

design which provides a tight, leak-proof seal. Listings below include natural caps. For color-coded caps, call Therapak customer

service for details.

• Containers are sterilized by gamma irradiation and labeled with a security tab, which has room

for patient information

• Ideal for pneumatic tube systems and other harsh transport conditions

• Containers are precision molded without the use of plasticizers or de-molding additives

• Sturdy, safe construction

• Easy to pour

• 2 sizes to choose from

Beaker Style Collection Cups with Pour Spout

These wide-mouth cups are ideal for initial collection of urine samples and subsequent pour off into transport

vials. Cups are available graduated to 90 mL and 180 mL and the durable, break-resistant design is still exible

enough for squeezing on sides to direct pour off. This cup is commonly used for collections involving substance

abuse testing. 74848S

• Markings on cap and container align to guarantee that the cap is correctly tightened

• Easy-to-read molded graduations at 50 mL increments

• Large easy-to-grip handle

Compact 3L 24 Hour Urine Collection Container

The compact container is manufactured using 100% virgin, chemically-resistant, UV ltering medical

grade plastic. This container is free of metals, latex, uorescence and is resistant to reagents that may be

used to preserve specimens. The slim design allows convenient refrigerator storage and easy handling

when stored in lock boxes. The closure system (cap and liner) has built-in features to prevent leakage

and maintain the integrity of the specimen during collection, transport and storage.

94667S

Duramark® Courier Products

Car Caddies are large capacity containers for specimen transport that t

well in most courier vehicles. Available in ve different internal congu-

rations, the Car Caddy provides multiple temperature possibilities within

the same container. Specimens requiring frozen, refrigerated, and ambient temperatures can be easily segregated while maintaining the

required temperatures of the individual specimen. In addition to the interlocking foam lids, a nylon mesh belt with a quick-release buckle

is utilized across the top to assist in securing the lids. The outer shell is composed of kelly green 4 mm corrugated plastic, which is both

durable and easy to clean. Built-in reinforced metal handles assure safe transport from the vehicle to the testing area. The interior is

available in two different materials - EPS foam inserts and urethane inserts. Please see below for available congurations.

36513S 36514S

• Multiple temperature capability

• High capacity

• Custom print and material colors available

Duramark® Car Caddies

The rolling courier tote is the ultimate in specimen collection mobility. Features include a water-proof PVC lining for easy cleaning and

a ‘pass through’ specimen top. This design allows the specimen to be inserted without opening the top, saving time. Zippered front

pocket can be used for paperwork or supplies.

Duramark® Rolling Tote

• Telescoping handle extends up to .6 meter

• PVC lining is water-proof and easy to clean

• Convenient ‘pass through’ top allows easy insertion

36776S ‘pass through’ specimen top

These convenient and portable courier totes offer lightweight versatility as well as durability for your specimen transport requirements.

Constructed of waterproof, scuff-resistant nylon material, the small courier tote includes a molded urethane insert, while the standard

size courier tote uses either EPS foam or a urethane insert. One divider is included to separate temperatures inside. Each courier

tote serves to protect the safety and integrity of frozen, refrigerated and room temperature specimens.

Duramark® Courier Totes

• Transports all three specimen temperatures

• Adjustable shoulder strap

• Custom print and fabric colors available

36508S 36510S / 36523S 36775S

Duramark® Courier Products 13

The fabric lock boxes are available in two standard sizes: small and large (see below for dimensions).

Features include a zipper closure, a mesh envelope for gel packs, and an adjustable strap for ease of courier

handling during pickup activity. Options include a zipper lock with 2 keys and a steel-reinforced security

strap to assure lock box safety during use.

Duramark® Fabric Lock Boxes

• Two stock sizes to choose from

• Includes inner mesh pouch for gel packs

• Custom print and fabric colors available

36501S

The ConstanTemp® features an insulated pouch combined with specially formulated

gel that holds temperature for extended periods of time. Frozen specimens can

be maintained for over 4 hours in 40°C temperatures. Condition the inner gel

packs to maintain the specimen temperature desired (frozen, refrigerated or

room temperature). ConstanTemp® is an ideal source of protection for maintaining

specimen integrity prior to courier pick up in lock boxes or in courier transit.

• Maintains specimen temperatures inside a lock box

• Gel packs hold temperature for extended periods

• Custom print and fabric colors available

Specimen Insulator for Lock Boxes

36748S 36741S 36596S36525S

All ConstanTemp® Specimen Pouches include 2 ConstanGel™ refrigerant packs.

Additional packs can be purchased separately.

Lock Boxes

The sturdy plastic lock box is made of high-impact polystyrene. Designed for hanging on the door using the optional straps, it offers

the timesaving convenience of a viewing window and a hinged door that opens down for ease of use. The metal lock box is

constructed of 24 gauge cold-rolled steel and painted with a powder coat nish for excellent strength and durability. It is insulated

on the inside with foam to assist with preserving the integrity of the specimens. A 90° stop hinge creates a ‘tray’ when the lid door is

opened for convenience. 3 different strap options are available: ‘Under the Door’, ‘Over the Door’ and ‘Extra Long Over the Door’.

Straps are shipped separately to save freight, warehouse space and for exibility of use.

Duramark® Plastic and Metal Lock Boxes

• Variety of strap options

• Durable construction

• Customization available

36744S

Metal Lock Box also available

with a combination lock.

36506S

Diabetes / Drug Testing 15

The glucose tolerance beverage is used to screen for hyperglycemia (diabetes mellitus and gestational

diabetes) and hypoglycemia (low blood sugar). The patient receives a precise dose of glucose and the

glucose level in his or her blood is then tested at specic time intervals. The non-caffeinated beverage

is orange avored and non-carbonated for easier consumption. The plastic bottles feature volume

graduations imprinted on the label to aid in dispensing smaller quantities.

TRUTOL® Glucose Tolerance Beverage

• Caffeine-free, non-carbonated

• Orange flavor

• Plastic bottles

Therapak’s Foil-Top kits include a 240 mL beaker style collection cup with pour-spout and

temperature strip. Each kit is sealed with a peel-off foil-top lid that secures the kit contents.

The single specimen collection kit features one 45 mL tamper evident ip top transport vial

and a transport bag with absorbent material. The split specimen collection kit includes two 45

mL vials and a transport bag with absorbent material. Flip top vials are graduated at the 15 mL

and 30 mL capacity level.

Foil-Top Specimen Collection Kits

• Foil-top lid seals kit components inside collection cup

• Includes 45 mL tamper evident vial

• Single and split kit configurations

Therapak assembles collection and transport kits using the popular 45 mL capacity tamper evident vial. The vial is constructed of virgin

polypropylene that results in excellent clarity for visibility into the collected specimen container. Each vial is graduated at the 15 mL and

30 mL capacity level. Kit congurations include a two-pouch specimen bag with absorbent, a 180 mL beaker style collection cup with

pour spout and either one or two 45 mL vials depending on whether your requirements call for single or split collection kits. Kit components

are heat-sealed in a bag to protect the integrity of the components. Customization available upon request.

Specimen Collection & Transport Kits

for Drugs of Abuse Testing

• Features wide-mouth collection cup

• Includes 45 mL tamper evident vial

• Single and split kit configurations

• Bag and box kits available

39468S

59794S

39449S

17 Tuas Avenue 9

Singapore 639197

+65 6862 4220

+65 6491 5849

10300S Singapore Catalog

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