ADALLEN PHARMA IS THE UK DISTRIBUTOR FOR AMD STERILE MEDICAL DEVICES & ANCILLARIES

SYRINGES & CLOSURE DEVICES

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AMD Sterile Transfer Sets & Accessories

A range of BD syringes, selected for their suitability for gamma sterilisation and compatibility with existing manufacturing procedures. CE marked and certified under ISO13485. Bespoke pack solutions such as different quantities per pouch or combinations of devices to meet specific procedure requirements bringing flexibility and scalability to any manufacturing process are also available.

Sterile Transfer Sets & Accessories AMD Luer Lock Combi Stopper

Designed to incorporate closing cones, the Luer locks are manufactured to ISO 594 and fully dye intrusion tested giving a qualified closure for all kinds of IV access connectors, needle free injection sites or closing aseptically manufactured pre-filled syringes. Manufactured from Gamma stable, high-density polyethylene. The AMD Red combi-stoppers are supplied in ‘rods’ of 5 or 10 caps to a ‘rod’. This to to ensure the vulnerable fluid pathway end is protected at all times, even when the pouch is opened by the technician. Caps may then be removed as required from the rod one by one. The last combi-stopper in the rod is protected by a white luer end cap.

Sterile Transfer Sets & Accessories

Pouches are constructed from a unique alcohol and VHP impermeable clear film which is suitable for all transfer methods. The metalised film half of the pouch provides a high visual background contrast, so that small and semi-translucent pouched devices may easily be inspected through the optically neutral transparent panel. The pouch incorporates reinforced pre-punched holes at the welded end, removing any need for additional steps prior to loading into a VHP gassing port.

Customised Procedure Packs

Many times an aseptic procedure may call for a combination of devices /components which do not exist within AMD’s standard configuration of products. At this point it is worth considering a bespoke approach. Speak to ADAllen Pharma concerning your requirements, our team will be pleased to assist you to find the right solution.

Needle & filter devices

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AMD Sterile Transfer Sets & Accessories Needles for Syringe Filling

The Terumo K-Pack II needle is designed to allow insertion into a secondary packaging. Each needle is encapsulated in an ergonomically shaped colour coded hard cap and case. This format ensures safety and compliance due to excellent aseptic technique. AMD standard PeroxyClear and PeroxyMet pouches are utilised to provide impermeability to alcohols and VHP. AMD have gamma-sterilisation-qualified the 19 Gauge and 21 Gauge 1½ inch (40mm) long versions for Aseptic usage. Both types are available in pouches of 5, 10 or 25 as standard.

AMD Sterile Transfer Sets & Accessories Filter Needles

Filter Needles for Syringe Filling
Filter Needle - Type 1 Braun
A 5 micron filter in female luer lock connector with 19 Gauge x 1½ inch (40mm) which is a thin wall needle for withdrawal or injection of medication from a rubber-stoppered vial. Components do not contain DEHP or natural rubber latex. Uniquely available with no paper packaging, and fluid pathway protected with a white luer lock cap.
Filter Needle - Type 2 Monoject™
A 5 micron filter in female luer lock connector with 20 Gauge x 1½ inch (40mm) which is an anticoring needle. Individually tested for proper filter seal, efficiency and flow rate. Components do not contain DEHP or natural rubber latex. Paper-free packaging, and fluid pathway and needle protected by plastic sheath and hub.

Vial Access Devices

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AMD Sterile Compounding Procedure Packs - Vial Access Devices

Filter Needle
A 5 micron filter, in female luer lock connector with 19 Gauge x 1½ inch (40mm), which is a thin wall needle for withdrawal or injection of medication from a rubber-stoppered vial. Components do not contain DEHP or natural rubber latex. Available with no paper packaging and fluid pathway protected with a white luer lock cap.
Chemo Pin
For the safe aspiration/injection from rubber-stoppered multi-dose vials where aerosolising of hazardous material is a potential risk. A 5μ filter in female luer lock connector with a 0.2 hydrophobic bacterially-retentive air filter providing venting and user protection. Easy to grip and universally viable (can be used on 13mm, 22mm and mm vials). Needle-free, the penetrating spike is a non-coring polymer design. Components do not contain DEHP or natural rubber latex or paper.

Vial Access - Vented Chemo Pins

Chemo Pins
For the safe aspiration/injection from rubber stoppered multidose vials where aerosolising of hazardous material is a potential risk. All have a 0.2 hydrophobic bacterially retentive air filter, providing venting and user protection. Easy to grip, and universal (all these Chemo Pins can be used on all vial sizes). They offer a needle free non-coring penetrating spike.
Components do not contain DEHP or natural rubber latex or paper. A 5μ filter in female luer lock connector with a
Chemo Pin - Type 1 B Braun
0.2µm hydrophobic vent only spike
Chemo Pin - Type 2 Codan
0.2µm hydrophobic vent only spike
Chemo Pin - Type 3 Codan
0.2µm hydrophobic vent only spike and 5 micron liquid filter

Vial Access - Non-vented

Monoject™ Smart-Tip™
Specifically designed to access rubber stopper medication vials.
Reduces chance of coring and particulate matter generation. The tip separates instead of tears, and there is no hollow bore to core.
Easier to draw-up viscous medication - Monoject™ Smart Tip draws medication at a rate equivalent to a 16-gauge 1 ½” needle.
AMD provide this product paperfree and protected by a sheath and luer cap.
Pack of 5 - Standard Product
Pack of 25 - Manufactured to Order

Cleanroom Cleaning

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Mopping Systems

FOR ROUTINE AND DEEP CLEANING OF ISO 5 TO 8 CLEANROOMS
AMD and Redditch Medical have co-developed the next generation of single-use, disposable cleanroom mops. The system is made up of a microfiber mop head packaged with a burstable pouch of rotational disinfectants, sporicide, or detergents.
Key System Benefits
Consistent quality of microfiber - single use 100% polyester and microfiber construction
- No deterioration of microfiber
- No risk of residue/drug carry-over from previous use
- No risk of fibre release from aged and/or damaged mop
- No-touch process of application to, and removal from, mop head
- Biocides are removed from the mop prior to activation to safeguard performance and bioavailability
- Rotational high level disinfectants, sporicide and detergent options are provided. A dry version is also available
- Each mop provides 20m2 to 25m2 coverage
- No contract required - just stock what is needed for deep cleans and/or routine use

Sterile Alcohols & Wipes

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Sterile GMP Transfer Disinfectants and Rapid Sporicides

We provide a complete range of reliable, powerful sterile disinfectant and sporicide solutions and burst-through impregnated wipes. All products are designed by Redditch Medical with the end-user in mind.

Pouches Sealers & Consumables

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Shawseal TS2 Touchscreen Pneumatic Pouch Sealer

On the TS2 seal, temperature, pressure and dwell time settings can all be changed. Operation is not available until the setpoints have been reached. These settings can only be altered via a PIN-protected screen. This provides an added layer of security.
Within the touchscreen interface are a number of useful tools. These include batch and master counters, a ‘calibration due’ and ‘calibration expired’ notification, as well as the ability to ‘data-log’ every seal actuation. Once activated, the seal temperature, pressure and dwell time are logged along with a time and machine serial number stamp. This data can then be exported out as a spreadsheet allowing the TS2 and its sealing process to be comprehensively validated.
A wide choice of options are available to allow customisation for each customer. The units are finished in stainless steel or powder coated. This makes them ideal for a cleanroom or laboratory setting.
Three sizes of unit are available starting at the ShawSeal PPS300- TS2 which can accommodate sealing widths up to 320mm. For widths up to 420 / 520mm, the ShawSeal PPS400-TS2 and PPS500-TS2 are the advised units. Units can be bench mounted or supplied with stand.

Sterile Purple and Yellow Clinical Chemo Waste Bins

Yellow clinical waste bin with purple lid and absorbent pads, supplied double bagged and sterile ready for easy transfer into a controlled area. Lid can be supplied attached or detached, if detached the lid is contained within primary packaging.
Manufactured under BS EN ISO 9001:2008 registered quality control systems and BS EN ISO 23907 - Sharps Injury Protection.
This product is intended for use by professionals, where clear identification of cytotoxic and cytostatic materials is required ensuring correct disposal of clinical waste.

Sterile Yellow Clinical Waste Bins

Yellow clinical waste bin with yellow lid, supplied double bagged and sterile ready for easy transfer into a controlled area. Lid can be supplied attached or detached, if detached the lid is contained within primary packaging.
Manufactured under BS EN ISO 9001:2008 registered quality control systems and BS EN ISO 23907 - Sharps Injury Protection.
This product is intended for use by professionals, where clear identification of clinical waste is required to ensure correct disposal.

Cleanroom Compatible Pens

AMD have made available two cleanroom compatible pens. Each is suited to ISO 5 GMP cleanroom use and are offered individually packaged and gamma sterilised.
Type 1
Simple ball point with low particle contamination mechanism:
- Black ink
- VHP and Alcohol impermeable packaging
- Batch coded
- Full C of C
Type2
Permanent super fine tipped marker pen. Writes indelibly on plastics and paper:
- Black ink
- VHP and Alcohol impermeable packaging
- Batch coded
- Full C of C

ISO 5 Cleanroom Chemo Preparation Mat

The AMD cleanroom chemotherapy agent protection mat has the following properties:
- Suitable for use up to ISO 5 areas as it is very low linting.
- Latex free.
- High liquid holding capacity, porous top layer, bonded reservoir layer and impermeable back layer.
- Mat Av. Size: 260mm x 200mm
- Packaged in a AMD’s VHP and Alcohol Impermeable PeroxyMetTM/PeroxyClearTM pouch, with an additional outer polyethylene bag.
Unique Cleanroom Packaging
This mat is packed to assist aseptic technique, and may be deployed in four easy steps:
1. Open pouch via easy tear ‘nick’.
2. Mat is folded impermeable side outward (the down facing side) and extract from pouch.
3. Place mat on surface where aseptic manipulations are to be safeguarded - impermeable (white) side down.
4. The mat will flatten out leaving the absorptive (blue) surface face up.