Manufacturing

Unique Manufacturing Capabilities

Ensign has extensive GMP manufacturing capability for creams, lotions, suspensions and flammable liquids in a broad range of formulating, filling and packaging processes. Our end-to-end service provides a comprehensive solution, from concept to market. This leads to faster turnaround times and greater efficiency, compared to relying on multiple vendors.

Market-leading Equipment and Technology

We continually invest in manufacturing equipment and technology to enhance manufacturing capability, capacity and quality and consistency.

• 14 formulating rooms providing scale, equipment redundancy and capacity to meet increased demand.
• Multiple mixing vessels ranging from 400L to 10,000L allowing “right sizing” of batches for efficient manufacturing.
• Flameproof, Vacuum and Cytotoxic vessels for different formulation requirements.

Quality Embedded at Every Stage

Ensign’s controlled sampling, dispensing and manufacturing environments meet TGA and FDA requirements for non-sterile manufacture. Pharmaceutical products, medical devices and cosmetic products are manufactured to the highest standards, including ISO 22716 and ISO 13485.

Ensign’s engineering team performs a full qualification process on all manufacturing equipment as part of the commissioning process. Our Process Validation team also performs process validations for any new therapeutic formulation and a full cleaning validation when necessary.

We use advanced automation and digital quality systems including proprietary electronic job sheets with embedded specifications and real-time signoffs. Our manufacturing vessels also have key parameters electronically logged, ensuring every step in production is visible in real time and nothing is left to chance

We are also audited regularly by both the TGA and our customers, including large multinational corporations with exacting standards.