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Design and Construction
What is a Type P620 Packaging?
A Type P620 Packaging (formerly referred to as a 1A container) is the highest integrity packaging for transport of infectious substances. Use of a Type P620 Packaging is required by section 5.16 of the TDG Regulations for infectious substances that could result in severe consequences if released during transport. A Type P620 Packaging is a UN standardized means of containment. The requirements for design, testing and marking of Type P620 Packaging in the CAN/CGSB-43.125 standard are harmonized with those set out in chapter 6.3 of the UN Model Recommendations on the Transport of Dangerous Goods.
How do I identify a Type P620 Packaging?
A Type P620 Packaging will have a UN marking on the outer packaging as set out in section 5.1 of CAN/CGSB-43.125. The following is an example:
- UN packaging symbol
- Packaging code (in this example, 4G represents a fibreboard box)
- The text “CLASS 6.2”
- The last two digits of the year of manufacture
- The country code for the country authorizing the allocation of the marking (e.g. “CAN”)
- The name or symbol of the manufacturer and other identification of the Type P620 packaging as specified by the country authorizing the allocation of the mark (e.g. design registration number).
Where can I get a Type P620 Packaging?
What are the basic features of a Type P620 Packaging?
A Type P620 Packaging is a triple packaging system consisting of:
- a) Inner packagings:
- leakproof primary receptacle(s);
- leakproof secondary packaging(s);
- b) a rigid UN Standardized outer packaging.
The assembled packaging must be capable of successfully passing the performance tests set out in section 7 of the CAN/CGSB-43.125 standard. These tests are based on those set out in chapter 6.3 of the UN Model Recommendations.
For transport of substances that are refrigerated, frozen or in liquid nitrogen additional requirements are set out in section 4.3.4, 6.13 and 6.1.6 of the standard.
How do I register as a Type P620 packaging manufacturer?
To register as a Type P620 packaging manufacturer, the applicant must submit an application to the Director. Each design of Type P620 packaging manufactured in Canada must also be registered by Transport Canada in accordance with section 10 of CAN/CGSB-43.125.
The registration process is initiated when the manufacturer submits an application for registration to the Director.
When the Director is satisfied that the requirements of CAN/CGSB-43.125 for registration are met, a Certificate of Registration will be issued to the manufacturer. The Certificate of Registration remains valid until its indicated expiry date (normally five years) or its revocation for cause. A renewal application must be submitted to the Director at least three months prior to the current Certificate’s expiry.
How do I register a Type P620 Packaging design?
All designs of Type P620 Packaging manufactured in Canada must be registered in accordance with section 10 of CAN/CGSB-43.125. The registration process is initiated when the manufacturer submits an application for registration to the Director.
When the Director is satisfied that the requirements of the CAN/CGSB-43.125 standard are met, a design registration number for the Type P620 packaging design will be issued to the manufacturer. The design registration numbers will be listed in Appendix A of the Certificate of Registration issued to the manufacturer.
What are the quality management system requirements for a Type P620 Packaging manufacturer?
A Type P620 Packaging manufacturer must have and maintain a quality management system for each facility manufacturing the packagings in accordance with 9.1 of the Standard.
Can I modify a registered Type P620 Packaging design?
Certain modifications may be made to the primary receptacles of a registered design without retesting, if the conditions specified in section 8 of the CAN/CGSB-43.125 standard are satisfied. Manufacturers must inform Transport Canada of any design changes in accordance with section 10.11 of the standard.
How do I renew a Certificate of Registration?
To renew a Certificate of Registration, the certificate holder must submit a written application for renewal to the Director at least three months prior to the current Certificate’s expiry.
How do I change the certificate holder name or address on a Certificate of Registration?
A Certificate of Registration is issued to an individual or to a corporate entity who is the certificate holder. A certificate of registration may not be conveyed from one certificate holder to another. A name change on a Certificate of Registration is only permitted if the certificate holder remains the same individual or corporate entity as before. In such a case the certificate holder may submit a written request to the Director to apply for an amendment to an existing Certificate of registration. The certificate holder’s address must be kept current. You must advise the Director in writing of any changes to the address of the certificate holder.
Please do not forget to indicate the date on which the change is proposed to become effective.
Is my Certificate of Registration for a Type P620 packaging design issued under the 1999 edition of the standard still valid?
The Certificate of Registration issued under the previous edition of the standard will remain valid until its expiry date or its revocation for cause.
Can I continue to use a type P620 packaging manufactured to the 1999 edition of the Standard or must I replace it?
You do not need to replace your Type P620 packagings, they are still considered to be in standard, however, you must ensure that all new requirements of the 2016 edition of the Standard are being met.
Where can I obtain more information?
Inquiries pertaining to applications for registration:
After choosing the language (1 for English, 2 for French), press option 1.
Please include the text "Packaging for infectious substances" in the subject line.