composite packaging system
Overview
The Purpose-driven & Eco-conscious CRSF pack at the cost of CT pack
Flexid takes pride in presenting the novel CRSF packaging system “Mediguard Pressfit”. Pressfit offers multiple key advantages of ‘Sustainability’ (reduction of polymer for the closure by 50%), ‘Cost advantage’ and ‘Patient convenience’. For the convenience of visually challenged users, Pressfit offers “Beads of tactile sensation” which provide Click sound and Tactile sensation while aligning the arrows. Following is the comparison between the conventional Push-down & Turn type closure against Mediguard Pressfit
| Parameter | Push down & Turn type closure | Mediguard Pressfit Composite Packaging System |
|---|---|---|
| Mechanism of operation |
Push down and Turn type
|
Match the arrows in the closure
and the container 
|
| Number of components |
Two components (Inner cap and Outer cap)
|
One component
|
| Weight |
33 mm : 6.0 grams 38 mm : 7.0 grams |
33 mm: 2.8 grams 38 mm: 3.2 grams |
| Sustainability | Push-down & Turn type CRSF Closure design was innovated more than three decades ago, when the polymer knowledge is primitive and the efficiency of injection molding machines has not matured enough to process precise components using the polymers. |
Material savings per One million closures: 33 mm: 3200 kgs 38 mm: 3800 kgs Significantly reduces the plastic consumption per unit. Helps reduce the carbon footprint in the environment. |
| Child Resistant Certification (CRSF) | Complies to CPSC (USA) / ISO 8317 test protocols | Complies to CPSC (USA) / ISO 8317 test protocols |
| Dimensional parameters | As per specification | No change in material of construction (MoC). Critical dimensional parameters like OFC, Head Space, OD, Height, Liner etc remains intact. Hence, regulatory pathway for implementation is minimal like Annual updatable |
| Moisture Vapour Transmission Rate (MVTR) | Complies to tightly closed containers requirement as per USP (10 mg / day / L moisture permeability) | Complies to tightly closed container requirement (10 mg / day / L moisture permeability) |
| Regulatory filing pathway | Filed product | Annual reportable as per Guidance for Industry: CMC Post approval changes to be documented in Annual reports (Ref.: CDER: CMC: March 2014) |
| Machinability | Proven performance on / CVC / Countec / IMA / Pharma pack lines | Comfortably works on the existing CVC / Countec / IMA / Pharma pac lines, with adoption of minor change parts like Centrifugal capper and Pressfit roller. Approx cost of implementation is Rs. 6.0 lacs to 7.5 lacs |
| Change over time | Approx. 02 Hrs | |
| Speed and Precision | Validated speed | Same validated speed can be maintained |
| Better access to the retail chains | Big pharmacy retail chains favour the organizations who adopt sustainable manufacturing practices which results in awarding the green points. Fulfils the Corporate Social Responsibility initiatives of the organizations. |
Patient convenience:
Pilot research on the users’ experience was conducted by interacting with several pharmacies and patients. It was noted that the concept of matching the arrows in the cap and bottle is predominant in the US market (Snap-off system) for OTC products. Patients are familiar with Snap-off concept. However, it was noted that with Snap-off, the patients experience inconvenience in matching the arrows due to poor finger grip and the need for continuous visual attention.
| Parameter | Snap-off system | Mediguard Pressfit Composite Packaging System |
|---|---|---|
| Design Excellence |
Match the arrows on the
closure and the container
|
Match the arrows on the closure
and the container
|
| Concept | Predominant in OTC products per se for decades in US | Can be used for OTC and Prescription drugs as the system is complying for CRC testing as per CPSC/ISO 8317 test protocols with high levels of compliance. CRSF test done by Bird Dog, USA. |
| Patient convenience |
As per market survey, it was noted a) Patients find it difficult to hold & turn the cap due to less height of the cap (7.2 mm) b) Continuous Visual attention is required to match the arrows of the bottle and cap. Poor compliance by the visually challenged and elderly patients
|
Based on the feedback a) Patient convenience is improved by increasing the height of the cap (to 11.2 mm) like conventional CT caps b) A mechanism of Tactile sensation is provided when the arrow mark on the cap and arrow mark on the bottle align with each other with a click sound facilitating the patient convenience. Even visually challenged and elderly patients can operate the pack with ease. 
|
| 1. Economical: |
Savings per
One million closures: 33 mm: Rs. 8,00,000/- 38 mm: Rs. 10,00,000/- |
| 2. Sustainable: |
Material savings per
One million closures: 33 mm: 3200 kgs 38 mm: 3800 kgs |
| 3. Patient centric: | User friendly pack to elderly patients and visually challenged patients |
In addition, Pressfit helps to upgrade from CT Pack to CRSF Pack at no extra cost and avoids accidental drug intake by the children
