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Pharmacy Shortage SolutionsPSS
Illustrative concept rendering of a mobile cleanroom interior — not an actual PSS facility
Missouri 503B Outsourcing

Building regional capacity for essential sterile medications

Mobile 503B outsourcing facility | Independence, Missouri

Discuss a PartnershipShare Institutional Medication Needs

53 ft

mobile cleanroom

ISO 7

buffer room class

ISO 5

critical aseptic zone

503B

FDA outsourcing pathway

Explore the cleanroom

Tap the numbered points to walk through the 53-foot mobile cleanroom.

Illustrative cutaway of a mobile cleanroom trailerConcept rendering

Zone 3 of 6

ISO 7 buffer room + ISO 5 hood

The core: an ISO 7 room surrounding an ISO 5 primary engineering control where critical aseptic work takes place.

Why a mobile 503B model makes sense

Tap any card for the background and source.

See all references →

Inside the concept

Roadmap

  1. 1

    Engage

    Partner with Missouri hospital pharmacies

  2. 2

    Fund

    First cleanroom equipment

  3. 3

    Build

    Design & qualify ISO 7 / ISO 5 environment

  4. 4

    Quality

    Stand up cGMP quality systems & training

  5. 5

    Launch

    Missouri licensure & FDA registration

Infrastructure

The facility

A mobile ISO 7 cleanroom with ISO 5 critical aseptic protection, cGMP quality systems, and Missouri pharmacist oversight.
Partnership

The focus

Working with hospital pharmacies on the sterile medication presentations they find hardest to source.

Help shape which sterile medications PSS plans for.

Share Medication NeedsDiscuss a PartnershipBook a 1:1 Call

Explore the venture

Our Approach →

How a mobile cleanroom and the 503B pathway work.

Medication Needs →

Share presentation and volume needs — no patient data.

Missouri Impact →

A regional vision rooted in Independence.

Infrastructure →

Preliminary equipment cost context.

Leadership →

Founder background and experience.

References →

FDA and ASHP sources on 503B and shortages.