Change control: Packo


February 28, 2018

The following information is intended for all of our valued customers who have purchased Packo inner seals. As part of our change control protocol, I would like to inform you about a proposed change to the raw material.

The Borealis Stamylex 5119S (MDPE) raw material, which we have been using for the manufacture of the Packo inner seals, has been discontinued by the manufacturer. Consequently, we are forced to switch to other materials.

The following products are concerned:

  • 4360-70-000         Translucent inner seal for Packos 300-1300 ml
  • 4365-00-000         Translucent inner seal for Packos 1500-2500 ml


We have selected alternative raw materials in order to be able to maintain the reliability of our supplies. We have satisfied ourselves that products manufactured from these materials meet all technical and quality requirements. These changes do not apply to Pharma Grade Packos.
 

Download the new Product Data Sheets


For your internal validation, the following items are available on request via your Inside Sales representative:

  • Samples
  • Specifications of Used Materials
  • Declaration of Compliance for Food contact
  • UN certificate
  • Declaration of Compliance Moisture vapour transmission


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 March 31, 2018. If you do not reply by this date, CurTec will assume that you have formally accepted this change.

From April 1, 2018, the Packo inner seals will be manufactured from new raw materials, in accordance with this notification.

Provided you can accept this change, we ask you to use the following article numbers for future orders:

  • 4360-71-000         Translucent inner seal for Packos 300-1300 ml
  • 4365-71-000         Translucent inner seal for Packos 1500-2500 ml


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

Kind regards,

Eef van Holland
Regulatory Affairs & Compliance Officer


Back

 

 



November 1st, 2016

The following information is intended for all of our valued customers who have purchased 300-500-650-1000- 300 ml Packos.  As part of our change control protocol, I would like to inform you about a correction of the UN engravings and the introduction of a material clock.

UN engravings

The UN engraving on the 300-500-650-1000-1300 ml Packo containers needed correction. The engravings have been modified so that they once again match the UN certificate and the product data sheet. These are the correct UN engravings:

   Product code Capacity UN number
   4303 300 ml  1H2/X0.4/Y0.6/Z0.9/S/--/NL/CURTEC-110503
   4305 500 ml 1H2/X0.7/Y1.0/Z1.5/S/--/NL/CURTEC-110503
   4306 650 ml 1H2/X0.9/Y1.3/Z1.9/S/--/NL/CURTEC-110503
   4310 1000 ml 1H2/X1.3/Y2.0/Z3.0/S/--/NL/CURTEC-110503
   4313 1300 ml 1H2/X1.8/Y2.0/Z3.0/S/--/NL/CURTEC-110504



 
 




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


Download the product data sheets


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 December 2016. If you do not reply by this date, CurTec will assume that you have formally accepted these changes.

From 1 December 2016, the 300-500-650-1000-1300 ml Packos 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


Back

 

 



April 1st, 2016

The following information is intended for all of our valued customers who have purchased 1500-2000-2500 ml Packos.  As part of our change control protocol, I would like to inform you about a correction of the UN engravings and the introduction of a material clock.

UN engravings
The UN engraving on the 1500-2000-2500 ml Packo containers needed correction. The Packaging code was stated incorrectly (1/H2 instead of 1H2). The engravings have been modified so that they once again match the UN certificate and the product data sheet. These are the correct UN engravings:

 

   Product code Capacity UN number
   4315 1500 ml  1H2/X2.0/Y3.0/Z4.5/S/--/B/CURTEC-080062
   4320 2000 ml 1H2/X2.6/Y3.9/Z5.9/S/--/B/CURTEC-080062
   4325 2500 ml 1H2/X3.3/Y4.9/Z7.4/S/--/B/CURTEC-080062



 
 


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

From 1 May, the 1500-2000-2500 ml Packos 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



Back

 



March 1st, 2015

The following information concerns all our valued customers who buy or intend to buy Packo small volume containers. 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 minor design change.

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, most Packo’s have 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 Packo 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 Packo's to make sure that they perform equally well or even better than the original PP version.

In order to further secure continuity of supply, we have also invested in new container and lid moulds.

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


Download the raw material change summary


Design change
In the past we have received feedback from customers that the screw lids were sometimes difficult to fit on Packo containers. This was caused by the tab on the tamper evidence strip which is attached to the lids. Sometimes it gets bent in the box during transport and folds inwards when placed on a container. Despite several modifications to our production process, we were never really able to fully eliminate this problem.

Therefor we made a minor design change to the lid and turned the tab of the tamper evidence strip upwards so that it cannot bend anymore. I have made a detailed summary of this design change.


Download the design 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 April 3rd, 2015. If you do not respond before this date, CurTec assumes that you will formally accept this change.

As of May 1st 2015, the Packo container and 1-component lid (4350) will be manufactured from HDPE. The Packo container in combination with 2-component lid (4370) will continue to be available in PP until further notice.

Valued customers who for some reason cannot accept HDPE as raw material, will still be able to order PP Packo’s with 1-component lid, but only as a customised item. 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


Back