Technical Specification of Disposable Syringes with Needle and Spirit Wipes

Міжнародний Альянс з ВІЛ/СНІД в Україні

вул. Димитрова, 5, корпус 10-А, 9-й поверх, 03680,м. Київ

Тел.: (+380 44) 490-5485

Факс: (+380 44) 490-5489

Е-mail:

Technical specification

disposable syringes with needles and spirit wipes

Quantity.

Lot 1.Syringes.

Total: 24 695080 items.

Lot 2. Spirit wipes

Wipes: 24 695080 items.

Requirements for syringes

Syringes must be produced from harmless material (polypropylene, polyethylene).

Syringesmust be transparent for air detection in it and for monitoring of solution level.

Calibration scale must be printed clearly.

Pistonmust move smoothly during the injection and it has to operate without shocks.

Syringes must be two-component. Piston must not be made of latex or rubber.

Pistonmust hold firmly and must not be unsteady.

While injecting liquid must not leak through piston.

Cannula must be located sideways from the center for syringes with volume of 5, 10, 20 ml.

Cannula and needle sizes must be universal and provide hermeticjunction in all possible combinationsof needles with syringes of different sizes.

Needles musthave three-edged grinding, silicon coverage and puncture effort not more than 0,30 Н.

Needle quality must provide severalinjectionssafely for veins.

Needle length for syringes with volumesof 5, 10, 20 ml is preferable to be no less than 40 mm.

Expiry date: 75 % but no less than 3 years from the date of delivery.

Packing and marking.

Syringes must be packed together with needles in stripes.

Each stripe must provide the following information in Ukrainian:

1) manufacturer name;

2) serial number;

3) month and year of expiry date;

4) inscription “sterile, apyrogenic, nontoxic”;

Stripes must be packed in boxes containing 100 or 80 items. The following must be indicated:

1) manufacturer name;

2) product title;

3) quantity of items;

4) serial number;

5) in case of deliveryon DDPterms boxesmustbemarkedwithstickersaccordingtotheartwork provided by the Alliance.Possibilitytoputthestickers or print the inscriptiononindividualpackageofeachsyringewillbeabenefit.

These boxes must be packed in uniformed bigger boxes. Syringes packing must correspond to ISO 7886-84 standard.

For easier distinguishing of syringes typesthe marking of its label on boxes must have the following color code: 1 ml — pink, 2 ml — blue, 5 ml — red, 10 ml — green, 20 ml — violet.

Spirit wipes.

Sterile, soaked withspirit disposable wipe for external usage only (for skin treatment before injection).

Composition: wipe made of nonwoven fabric (polypropylene), approximate size - 30х65 mm, impregnated with 70% spirit solution.

Sterilityterm is no less than 3years.

Package type: sterile individual paper-foil pack.

In case of deliveryon DDPtermsboxes with wipes (containingaround 100 items) mustbemarkedwithstickersaccordingtothe artwork provided by the Alliance.

Possibilitytoputthestickers or print the inscriptiononindividualpackagewillbeabenefit.

Expiry date: 75 % but no less than 2 years from the date of delivery.

Quality Control.

Commodities must be subjected to toxicological, sanitary, microbiological and mechanical control in the laboratory of the manufacturer in accordance with ISO 7886-84 standards.

Results of control must be indicatedin acorresponding protocol.

Together with each consignment the supplier must provide acertificate of quality.

Conduction of quality analysis made by an independent laboratory will be a benefit.

Alliance asks potential suppliers to provide 50 syringes of each size, 50 needles 0,33х13 and 100 spirit wipes as samplesfor conducting additional quality control.

Provision of samples is obligatory for taking part in the bidding.In case the samples are sent from abroad it is necessary to contact the bidding organizer in order to obtain instructionsconcerning the form of the documents for sending the samples by mail. In case these instructionsare not followed theAlliance will not be able to release the parcel from customs control.

Samples must be delivered at least before the proposals submission deadline.

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Termsofdelivery

Syringesandspiritwipesaretwoseparatelots. According to a decision ofthe Procurement Review Committee both lots can be procured eitherfrom one supplier or from different ones.

Save price,the following criteria will be taken into account: quality of the goods (with consideration of QC results and feedbacks of end users after samples testing); supply terms and details of the bid (including possibility of distribution, stickering, etc.); previous experience of product usage, if any (feedbacks of end users); reliability, stability and reputation of the supplier; previous experience of work with the supplier, if any; etc.

PricesmustbeindicatedaccordingtothetermsofCIP KyivorDDP (with delivery approximately to 100 addresses in all regions of Ukraine)in USD, EUR or UAH.

Taking into consideration the unpredictable situation with customs legislation regarding import of syringes it is proposed for bidders to indicate price of syringes procurement according to CIP Kyiv terms as well as DDP terms.

The goods will be delivered in two or three consignments during one year starting from the first delivery. Each of the consignments will be paid separately on terms of 50% advance payment and the final payment upon delivery.

The first consignment must be ready to be delivered to the regions of Ukraine by the end of November 2010.

Possibility of distributionof the goods to the regions of Ukraine will be anadvantage.

At that, the supplier will be responsible for goods delivery to warehouses of recipients.

The supplier will also note numbersof batches shipped to each of the recipients.

Alliance has the right to increase or decrease the procurement volume within 20% from the whole volume indicated in this specification.

Bid contents

Participants are required to submit the following documentation as company’s bid:

1. Copy of original documents on bidder’s state registration in accordance with local legislation.
2. CopyofvaliddocumentationissuedbytheregulatoryauthorityofUkraineallowingusageoftheproduct on the territory of Ukraine(Registration Certificate).
3. Copyoflicenseoranothersales permit issued by regulatory authorities of the manufacturer’s country.
4. Copies of 5 certificates of analysis (conformity) for different batches of the goods manufactured earlier.
5. Samples must be submitted together with bid proposal.

All documents submitted as the bids must be written in one of three languages (Ukrainian, Russian, English) or translated in one of the named languages.