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Case Study · Central Africa

Integrated IV Fluid Manufacturing Project, Congo

An integrated pharmaceutical manufacturing programme bringing container production, IV filling, cleanroom engineering, utilities and packaging together as one coordinated production system.

IV / LVP Manufacturing ISBM Technology Cleanroom & HVAC Turnkey Engineering
LocationCongo · Central Africa
Project Records2022–2024
Core TechnologyPreform Injection + ISBM + Filling
StatusReported in Production
01 · Project Overview

Container Production and IV Filling as One System

The project was structured around producing pharmaceutical plastic IV containers in-house and integrating them directly with the filling line and supporting facility infrastructure.

01

The Requirement

Container forming, filling, sterilisation, inspection and packaging needed to operate as one coordinated workflow, supported by pharmaceutical water and controlled production environments.

02

Hawkland's Approach

Preform injection, ISBM blowing, IV filling, cleanroom, HVAC, process piping, chilled water, electrical systems and packaging were organised under one project framework tied to the manufacturer's URS.

02 · Project Scope

An Integrated Manufacturing Architecture

01

Preform Injection

In-house production of pharmaceutical plastic preforms for subsequent bottle forming.

02

ISBM Bottle Forming

Injection stretch blow molding integrated into the production architecture.

03

IV Filling

Filling equipment interfaced with the bottle-production line as one process.

04

Cleanroom & HVAC

Cleanroom construction, ducting, chilled-water piping, airflow components and pressure monitoring.

05

Utilities

Process piping, drainage, valves, electrical panels, cable trays and chiller infrastructure.

06

Packaging

Flow packing and labeling integrated with downstream product handling.

07

Qualification

Qualification planning includes FAT/SAT and DQ/IQ/OQ/PQ under Hawkland's methodology.

08

Training & Support

Technology transfer, operator training and after-sales service form part of the wider lifecycle approach.

03 · Production Route

From Raw Materials to Finished IV Product

01Raw Materials
02PW / WFI
03Compounding
04Filtration
05Preform Injection
06Stretch Blow Molding
07Filling & Closure
08Sterilisation
The final manufacturing route, sterilisation cycle, cleanroom classification and detailed engineering parameters are confirmed against the product URS and regulatory requirements.
04 · Technology Planning

Capacity Matched Through ISBM Configuration

Project records document multiple ISBM cavity configurations, allowing line configuration to be matched to the manufacturer's required production capacity.

4-Cavity

Documented ISBM configuration option.

6-Cavity

Intermediate capacity configuration.

8-Cavity

Higher-output documented configuration.

05 · Project Value

Why an Integrated IV Programme Matters

In-House Container Production

Container forming becomes part of the manufacturer's own production system.

Integrated Engineering

Process, cleanroom, HVAC and utilities are coordinated together.

Qualification Readiness

Validation planning begins alongside engineering instead of after installation.

Long-Term Scalability

Line configuration can be matched to production volume and future expansion.

Planning an IV / LVP Project?

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