Case Study 05 · IV Bag Assembly & Filling

Aseptic IV Bag Fill-Finish & Automated Overwrap Line

A large hospital supply manufacturer expanding its saline and dextrose IV bag capacity needed a complete aseptic fill-finish, port welding, visual inspection, and overwrap packaging line — ISO 5 / Class A environment, 1,200 bags per hour.

$8.2M

Program Value

20 mo

Sales Cycle

Buying Influences

Won

Outcome

Background

The Opportunity

Following an FDA shortage designation for large-volume parenterals, a hospital supply manufacturer received federal procurement support to expand domestic IV bag production. The capital project required a complete greenfield aseptic fill-finish line for 250mL, 500mL, and 1,000mL polypropylene bags — encompassing bag forming, media fill, port welding, visual inspection (particulate and seal integrity), label application, and automated overwrap and palletization.

The integrator was engaged through a sole-source justification process as strategic advisor and prime integrator, given prior Class A cleanroom automation credentials and domestic production urgency.

Confirmed federal procurement backing; $10M capital envelope available
Validated aseptic processing requirement: ISO 5 fill zone, ISO 7 background
Identified champion: VP of Sterile Operations — had authored the expansion proposal
Confirmed FDA shortage designation created regulatory fast-track opportunity
Verified no other domestic integrator had recent Class A aseptic line credentials
Confirmed throughput target: 1,200 bags/hour validated across all three bag sizes

Stakeholder Map

Buying Influences

Role	Name / Title	Influence	Mode	Key Concern
Economic Buyer	Chief Operating Officer	Executive sponsor, board presenter	Growth	Federal procurement compliance, delivery date
Economic Buyer	CFO	Capital approval, federal fund management	Overconfident	Milestone billing tied to federal disbursements
Technical Buyer	VP Sterile Operations	Aseptic process and URS authority	Support	Media fill and environmental monitoring
Technical Buyer	VP Quality & Compliance	cGMP / FDA compliance gatekeeper	Overconfident	Particulate inspection AQL, seal integrity
Technical Buyer	Dir. Engineering	Facility integration and utilities	Even Keel	HVAC interface, cleanroom certification scope
User Buyer	Sterile Manufacturing Manager	Line operations and changeover	Even Keel	Gowning zones, operator ergonomics, OEE
User Buyer	Validation Manager	Process validation protocol ownership	Overconfident	Media fill simulation protocol depth
User Buyer	Procurement Director	Contract terms and vendor qualification	Even Keel	Federal procurement flow-down requirements
Coach	VP Sterile Operations	Internal champion, expansion proposal author	Support	Wants project tied to his strategic vision
Coach	FDA Liaison Consultant	External regulatory credibility	Growth	Fast-track validation strategy for shortage response

Sales Process

Engagement Flow

Win Strategy

Win Checklist

#TypeAction ItemOwnerDue DateDone

1 Internal Alignment Assemble aseptic fill SME team — assign lead process engineer with Class A LVP experience Jake Malone Month 2 YES

2 Customer Engagement Joint facility walkthrough with COO and VP Sterile Operations to define cleanroom expansion boundary Collin Phelps Month 3 YES

3 Technical Alignment Develop media fill simulation protocol for all three bag sizes in collaboration with Validation Manager Chris Columbus Month 9 YES

4 Commercial Alignment Structure federal billing milestone schedule aligned to HHS procurement disbursement gates Anna Watts Month 14 YES

5 Customer Engagement Arrange reference site visit to comparable aseptic LVP line for VP Quality and Validation Manager Collin Phelps Month 10 YES

6 Technical Alignment Validate particulate inspection detection rate at AQL 0.65 across 250mL, 500mL, and 1,000mL bags Chris Columbus Month 12 YES

7 Commercial Alignment Engage FDA Liaison Consultant to co-develop fast-track validation strategy and eCTD submission narrative Anna Watts Month 11 YES

8 Internal Alignment Legal review of federal flow-down clauses (FAR/DFARS) and IP ownership terms in prime contract Jake Malone Month 17 YES

Why We Won

Key Win Factors

🏥

Sole-Source Credentials

Our team's documented Class A aseptic automation credentials were the only ones in the domestic integrator market — the sole-source justification was factually straightforward to support.

⚡

Fast-Track Validation Strategy

Partnering with an FDA Liaison Consultant to build a shortage-response fast-track validation narrative gave the regulatory team a submission path no competitor could match on timeline.

💰

Federal Billing Alignment

Structuring our milestone billing to map exactly to HHS procurement disbursement gates removed the CFO's cash flow risk — a detail no other integrator bothered to understand.

🔍

Media Fill Protocol Depth

Delivering a draft media fill simulation protocol for all three bag sizes during the proposal phase — rather than post-contract — gave the Validation Manager confidence before PO signature.