Change control: Click PackX


April 1st, 2016

The following information is intended for all of our valued customers who have purchased Click Packx.  As part of our change control protocol, I would like to inform you about a change to the product geometry of the integrated gasket, a new product for the integrated gasket and the introduction of a material clock.

Change to the product geometry of the integrated gasket

Changing the material from PP to HDPE has meant that the gasket on the Click Packx has become heavier as a result of the different shrinkage properties of the materials. This why there have been delays in delivering samples. On 1 October 2015, we informed you about this through a change notification.

The gasket has now been thoroughly analysed. We used this analysis to optimise the gasket design. This has led to a final solution that has a comma shape. We have reduced the closing force and improved the water vapour density. The comma lip is made from a new type of TPE material with a lower hardness than the previous version of the lip. The final solution with the new gasket design has been tested over the last months for migration and water vapour density with positive results.

In order to better guarantee the delivery reliability in the future, we have chosen a second supplier for the TPE of the integrated gasket. The ‘Specification of Used Materials’ and the ‘Declaration of Compliance’ for contact with food have been extended with this new material. The ‘Specification of Used Materials’, ‘Declaration of Compliance’ and new samples are available on request through Inside Sales.

Material clock
CurTec is introducing a material clock. The material clock is a configurable clock that shows the materials used. Each letter of the clock corresponds to a specific material. These letters together with the respective materials are described in the UN certificate. The container moulds will be modified in April. The material clock will be placed on the bottom of the container. The UN certificate is available on request thrugh Inside Sales.
 

Download the summary of changes


Acceptance
Please read this information carefully. If you require any additional information in order to introduce this change into your quality system, please contact us before 1 May 2016. If you do not reply by this date, CurTec will assume that you have formally accepted these changes to the gasket. The introduction of the material clock is an irreversible alteration to the mould.

From 1 May the Click Packx will be manufactured in accordance with this notification.

For further assistance, please e-mail me: change.control@curtec.com

Kind regards,

Eef van Holland
Regulatory Affairs & Compliance Officer



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October 1st, 2015

The following information concerns all our valued customers who buy or intend to buy Click PackXOn May 1st we notified you about planned changes to Click PackX . We announced the change from PP to HDPE as standard material for both container and lid and we introduced a new raw material for the integrated gasket which complies with food safety regulation EC 10/2011. The following information contains additions to this change control procedure.

Originally we would have started production of these new items on July 1st. However, as it turned out, the new gasket material causes relatively high friction and need more force to close  than we would like. In the past few months we have tried to reduce the force needed to close the lid but so far we have not succeeded. For that reason we were not able supply any samples. We apologize for the delay.

The change in food safety regulation EC 10/2011 will be effective as of January 1st 2016 after which we cannot market lids with the current gasket inside the EU as food safe anymore. This does not affect the change of the standard raw material from PP to HDPE. The base material HDPE is fully complient to food safety.

For all food applications inside the EU
At this moment we can supply a (EU) food safe Click PackX in HDPE with the new EC 10/2011 compliant gasket material. These  lids require relatively high force to close due to higher friction of the gasket. The lids do not require more force than usual to open.

For all non-food and FDA applications
The current gasket material meets US food safety regulations 21 CFR 177.1210 and 21 CFR 177.2600 and is also suitable for all non-food applications. For customers in these application areas we will start manufacturing a Click PackX in HDPE with a gasket of the current raw material. The lid will bear a food safe logo.

This leads to the following options for the supply of Click PackX. I would like you to carefully review these:

1. Click PackX HDPE without food safe logo
For customers with a non-food application, we offer Click Packx  in HDPE with an integrated gasket in the current material. Both container and lid do not bear a food safety logo anymore. Samples can be ordered through Inside Sales. These new items will be manufactured and available for shipment as of December 1st. These products are available with the following product codes:

Lid:    4515-70-611
Containers:    4515-60-004
  4520-60-004
  4525-70-004


2. Click PackX HDPE with food safe logo (USA)
For customers with FDA compliant applications, we offer Click PackX in HDPE with an integrated gasket in the current material. The lid will bear a food safety logo. Samples can be ordered through Inside Sales. These new items will be manufactured and available for shipment as of December 1st. These products are available with the following product codes:

Lid:    4515-80-611
Containers:    4515-60-004
  4520-60-004
  4525-70-004


3. Click PackX HDPE with food safe logo
For all customers with food applications inside the EU, we offer a Click Packx  in HDPE with an integrated gasket in the new EC 10/2011 compliant material. Samples can be ordered through Inside Sales. These new items with food safety logo will be manufactured and available for shipment as of December 1st. These products are available with the following product codes:

Lid:    4515-60-611
Containers:    4515-60-004
  4520-60-004
  4525-70-004

The food safety logo will be removed from the container and placed in the lid. Please consult the new product data sheet for exact details.

Accessories: In order to facilitate the closing of a Click PackX HDPE with food safe logo, CurTec offers a tool which makes turning the lid easier. Samples can be requested through Inside Sales. We will continue to optimise the gasket in order to achieve a closure that requires similar force as the current Click PackX lid. We expect to realise this by april 2016 and will inform you at that time.

4. Click PackX PP with food safe logo (current version)
The Click PackX in PP with integrated gasket in current material and food safety logo can be ordered until November 1st 2015. Delivery should take place before January 1st 2016. You can choose this option should you wish to create safety or transit stock. These products are available with the following product codes:

Lid:    4515-00-611
Containers:    4515-00-004
  4520-00-004
  4525-00-004


Can you please let us know before November 1st which of the above options suits you best? Your CurTec account manager will contact you shortly. In case we do not receive any response from you, we assume you would like to receive Click PackX in HDPE without food safety logo (option 1).

By executing these changes, we can assure continuity in delivery of Click PackX  for the years to come and the supply of a reliable and compliant packaging solution.

In case you need further assistance or information, please contact your account manager or Inside Sales or e-mail me: change.control@curtec.com

Kind regards,

Eef van Holland
Regulatory Affairs & Compliance Officer



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May 1st, 2015

The following information concerns all our valued customers who buy or intend to buy Click PackX. As part of our change control protocol, I would like to inform you about a planned change of raw material used for containers and lids and a change of raw material used for the integrated gasket.

Raw material change

The EU legislation (EC 10/2011) on materials for food contact is about to change. As of January 1st 2016, all plastic packaging materials must comply with newly defined overall migration limits. CurTec wants its packaging products to comply with the new food contact regulation. Recent analysis however showed that we cannot achieve that goal to our satisfaction with all our raw materials and colorants.

Until now, Click PackX has been manufactured of one PP brand for which we have no suitable alternative brands. In order to secure continuity of supply, we have decided to switch to HDPE as raw material for all Click PackX containers and lids. We have sufficient alternative HDPE brands available to us with a higher reliability of supply.

Before choosing HDPE, we made sure it fulfilled all our technical and quality requirements. Our R&D department has extensively tested HDPE Click PackX to make sure that it performs equally well or even better than the original PP version.

CurTec also decided to select new raw materials for the manufacture of the integrated gasket because we cannot guarantee that the current material will comply with the new regulation. We have already approved one material and are testing a second one. As soon as it has been approved, you will be notified.

For your reference, I have made a detailed summary of all relevant technical data, available certificates and other background information. Please be aware that the product codes have been modified. Also the lay-out of and information on the product data sheets has been updated. The packaging units remain unchanged but no longer appear on the product data sheet.


Download the raw material change summary


Acceptance
Please review both documents carefully. Should you require additional information to process this change in your quality system, please contact me by e-mail before June 1st 2015. If you do not respond before this date, CurTec assumes that you will formally accept this change.

As of July 1st 2015, Click PackX will be manufactured from HDPE. The lid will also have an integrated gasket of the new material.

You can place a final order of the current version until June 15th 2015. Valued customers who for some reason cannot accept HDPE as raw material, will still be able to order PP Click PackX, but only as a customised item and without a UN marking. Our Inside Sales department can inform you about the delivery terms of customised items.

For further assistance, please e-mail me: change.control@curtec.com

Kind regards,

Eef van Holland
Regulatory Affairs & Compliance Officer


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