How to make our Packaging Material specification?

September 4, 2020May 16, 2023 Vihaan Nagal 0 Comments

Definition of Packaging Material specification:

It is the tool for checking the quality and pricing calculator of packaging material.

What is the packaging material specification?

The packaging specification is one of the very critical aspects of any organization. The ultimate purpose of a specification is an agreement document between the purchaser and supplier. However, a provisional or outline specification is essential, even when initial development samples are being surveyed since it provides both a disciplined approach to the examination of materials and components and a record of exactly what was received, used, etc.

A specification is represented as a list of tests, references to standard procedures (like – ASTM & ISO), and appropriate tolerance measures, including numerical limits, series, or other standards for the tests described. It sets the requirements to which a new packaging material should conform to be considered acceptable for its intended use.

“Conformance to specifications” indicates that the packaging material specification will meet the listed acceptance criteria when tested according to the documented standard procedures.

Specifications are significant quality standards proposed and maintained by the manufacturer and approved by regulatory authorities as approval provisions.

The packaging material specification must be divided into three categories:

Step 1# A general overview of packaging material for tracing

Step 2# Physical Measurement and other tests (destructive and non-destructive test)

Step 3# Packing Instruction for logistic (packing for transport from supplier side)

A packaging specification is usually documented under the following layout headings:

General Overview:

• standard title (bottle, cap, laminate, etc.)

• specification reference number and date have written

• previous edition/specification ref. No.

• general description of the item.

• materials of construction—types, grade, color, etc.

Physical Measurement and other tests (destructive and non-destructive tests)

• construction, the process by which constructed; size/weight/capacity, with tolerances (maybe under a drawing reference)

• drawing ref., date, details of dimensions and tolerances

• decoration, a component of print, decoration method, color target(s), artwork reference, etc.

• performance tests (concerning test method, number, etc.)

Transport Instruction of packaging material from the supplier side

• how to be delivered and identified

• signatures of approval: supplier/purchaser

Packaging specification template

Here is a general overview of the packaging material’s content, but the central part of the packaging specification is measurement parameters.

The measurement parameters started from visual appearance and then needed to specify the available measuring such as length, width, and diameter values. After next, it has to set the value of functionality tests such as sealing and torque testing. Then, add performance tests such as transport worthiness tests(Drop, Vibration, and Stack load test). And then has to add aesthetical tests such as artwork and Pantone color of the packaging material.

The tentative idea to address any packaging material to analyze – start from the basics: such as visual, dimensional analysis, aesthetical appearance, functional test, performance test, safety, and security features, and artwork.

Add-on features

This all above parameter is to be defined based on packaging material type. Some Inspection procedures and acceptable quality levels (AQL’s) related to critical, major, and minor defects may be part of the specification document but are more likely to be in a general information support manual unless these are specific to the item concerned.

Benefits to Packaging Technologist

Packaging Technologists are forced to examine a problem by drafting a technical spec before going straight into packaging material code, overlooking some aspects of the solution.

Time-wasting is reduced, especially when integrated. Specs should never run short. Instead, they should be in excess.
The scalability of managing teams is simple since the process is already drawn, and new developers understand the technical requirements without pressure. The entire group can work on a large project without confusion and any problems.
It offers developers a specifically defined contingency plan, so you don’t end up with the “failing to plan planning to fail” poster child. The chances of failure are reduced since the supplier knows the specifications and works within the plan.

Compatibility:	proof that no serious interaction between container closure material and content occurs that leads to altering efficacy and stability of the product or that presents a risk of toxicity.
Container closure system	the sum of packaging components that together contain and protect the active substance or the dosage form. This includes immediate packaging components and secondary packaging components, if the latter are intended to provide additional protection to the active substance or to the drug product.
Extraction studies:	testing that specifically involves exposing a sample of the component to an appropriate solvent system at extreme conditions in order to maximise the amount of extractables from the packaging in the solvent.
Interaction studies:	studies to detect any effects between plastic packaging component and product leading to unacceptable changes in the quality of the product or the packaging under normal storage/use conditions.
Migration:	release of substances (leachables) from the plastic component into the content of the container under conditions which reproduce those of the intended use.
Packaging component:	any single part of a container closure system including containers (e.g. ampoules, vials, bottles), closures (e.g. screw caps, stoppers), stopper overseals, container inner seals, administration accessories and container labels.
Plastic material:	a material that contains one or more organic macromolecular compounds obtained by polymerisation, polycondensation or polyaddition or any other similar process from molecules with a lower weight or by chemical alteration of natural macromolecules as an essential ingredient. Elastomeres and natural and synthetic rubber are not within the scope of this guideline.
Sorption:	bonding of a solute to a plastic packaging component as a physicochemical phenomenon related to the properties of the packaging material and the chemical properties of the active substance or other soluble substances in the preparation.
Specification:	a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria as appropriate for the tests described.
Suitability:	assessment of the container closure system in regard to protection, safety, compatibility and performance (function).