I have been involved in basic research for more than 10 years for innovation of wide range of pharmaceutical products New “ Packaging design for Drug delivery” like “ Solid doses, Injectables (for anticancer, HIV, wide range of vaccines, Covid-19 drugs and Biosimilar products) in“ Microgravity Environment like MARS mission. Looking at the present ecological imbalance Scientists are thinking for multiplanetary living system in order to survive human species. As we know different planets having critical climatic conditions and Packaging will play a vital role. We as a scientist have clear vision about things are going to happen after 100years in other planets and from now we have to keep ready “ Packaging designs and delivery systems” for life savings drugs and essential medicines for Astronauts and visitors.

Mars vs earth comparisons

Mars

Climatic conditions

Note: Also observed : water, nitrogen oxide, neon, hydrogen-deuterium-oxygen, krypton and xenon

Surface temperature, Atmospheric pressure, Atmospheric composition, Carbon/oxygen cycles, Nitrogen cycles, Magnetic fields, achieve temperatures and pressures similar to standard atmospheric temperature and pressure here on Earth.

How Injectable device will work in MARS

1. Draw up the drug by the needle from the vial with the piece labelled “1” and lock it in place by rotating it to the side.
2. Load the spring by pulling both bars labelled “2” into the slots at the end.
3. Before administrate the drug, press the device against your leg or arm and release the bars from the slots. This will release the spring and simultaneously push the needle into the body and inject the medication. The device and the container should be printed out of plastic, and the needle should be printed from stainless steel. It is designed for both the microgravity trip and the one-third gravity of Mars.

High radiation in microgravity and packaging solutions

Tablet/capsule dispensing(manual operation)

Packaging for solid doses products (Microgravity)

Recommendations

1. In order to avoid extreme heat and radiation better to use “ Multilayer bottles ( black coating inside)
2. Outside and inside “Black ink (food grade)layer need to use.

Packaging for “Injectable” (Microgravity)

Recommendations

1. Outer surface of the “ Vial, PFS and cartridges” should be “ Lacquer with gold ink”
2. You can go for “black /gold lacquering”.

Bubble free injection syringe in space a big challenge

1. During or before administration on Earth we are rarely facing “Air bubble “formation inside the syringe. Whereas on MARS it’s common due to low gravity.
2. A single air bubble into a crewmember is harmful. 

Recommendation: Applied “ Electromagnetic field” inside the “Auto injector” to infuse the Air bubbles.

We can avoid delamination inside the syringe if we use following

1. Plunger inner surface can be coated with “ Silicon oil”
2. Change of “ Sterilization process”
3. Can be use COC/COP syringes.
4. Possible to use “Fluoropolymer coating” inside the syringe surface.
5. Rectification of product formulation i.e reduce Ph of the product if possible.

Extractable and leachable are most important for inhalers and catheters.For an extractables from a device component the AET (μg/g) can be determined using Equation 1: Equation 1

$AET= SCT.D_t$

D_d m

 D_d- Doses per day

D_t- Total Labelled doses

m - mass of component

The AET (μg/device) for a drug delivery device (e.g. an MDI) can be determined from Equation 2

$AET= SCT.D_t$

D_d

 D_d- Doses per day

D_t- Total Labelled doses

Delamination of Glass, inhaler and catheters

There are many cases we observed Astronauts are facing breathing problems, so this is advisable they should carry sufficient numbers of “Inhalers”. Packaging technologists are playing major role for selection of primary packing materials, designing and final packing.

We should be very much careful to avoid corrosion, leakage, extractable & leachable. Better not to use any colored lacquers inside surface of the “Inhaler cylinder. Design has to be validated.

Eye ointments packaging

As you know due to extreme heat and radiation “Fluid of eyes” get dries, so Astronauts need to carry “eye ointments” those should have single dose” and make sure 100% product will come out in one press. Recommend to use “LDPE or LLDPE” for primary packaging materials. One strip should contain 5 tubes and should be vacuum packed.^1–5

Nitrocellulose patches packaging

Burning skin is the most common thing in Microgravity environment. So Astronauts and visitors have to carry sufficient numbers of this item. This has to keep in a cool place and packed in a “ Gold lacquered” Tin or Aluminium box.

Risk ratings and dispositions per design reference mission (DRM) category

Medical device regulations for space (Drafting is going on)  

Medical device safety

1. Medical device safety and risk management
2. Effectiveness/performance of medical devices
3. Phases in the life span of a medical device
4. Participants in ensuring the safety of medical devices
5. The role of each participant/stakeholder
6. Shared responsibility for medical device safety and performance

Governmental regulation of medical devices

1. Critical elements for regulatory attention
2. Stages of regulatory control
3. A common framework for medical device regulations
4. Regulatory tools and general requirements
5. Product control
6. Vendor establishment control
7. Post-market surveillance/vigilance
8. Quality system requirements

There has been no conflict of interest in the preparation of this study.

Authors declared no conflicts of interest.

None.

1. Humans in Space. India: NASA.
2. International Space Station (ISS). India: NASA.
3. Space Station Research and Technology. India: NASA.
4. Handheld Diagnostic Device Delivers Quick Medical Readings. NASA SPINOFF. NASA Technology Transfer Program.
5. Custom Packaging Solutions for Aerospace and Space. Larson Packaging Company.