Animal Healthcare Business and Engineering Alignment
Challenge from the Client
Our CMO client needed to increase production capacity of a canine and feline topical solution, protecting against ticks and fleas, to meet the projected demand of an additional 30 million tubes. This true solution containing acetone is to be filled into tubes with 5 different fill volumes from 04.ml to 5ml, induction sealed, and wrapped in a sachet. Special attention is paid to the Acetone component since it requires complying with ATEX requirements and is an ‘aquatoxic’ environmental risk.
Our Approach & Solution
IPS was to copy the client’s existing compounding installation in the USA to another EU manufacturing facility, modifying the process where required to cater for EU rules & regulations including ATEX requirements. This project would be extremely complex with long lead times for process equipment along with the storage of dangerous goods on site.
The accelerated schedule has been the primary driver in defining the design and engineering approach during the detail design and construction phases which included a number of key activities being completed during FEL3 and earlier:
- Ordering of long lead filling and packaging line, and early development / approval of URS. During FEL2 only minor modifications have been made to the design and specification of this item, with close cooperation from the process equipment vendor (IWK),
- Early submission and approval of the initial building permit,
- Modular design / build with offsite fabrication e.g. “Super-Skid” for compounding, modular cleanroom, modular transformer & switchgear, precast structure (stair tower / planks, walls, etc). A compounding package for the whole of the compounding skid was assembled during FEL3 and tendered early.
- Surveys: soil investigation completed, geotechnical prepared.
- Project designed within the constraints of the existing site environmental licenses (e.g. acoustics, air emissions, drainage, hazardous environments, and quantities of hazardous materials in storage or process.) which added to the overall design challenges.
IPS process design team improved the process where there had been recognized issues at other facility:
- Powder delivery & containment – using an Ystral system for in-line API powder mixing to meet standards on solid exposure control. A drum lift to add API to the compounding tank was previously used.
- Removal of Acetone buffer tank – now acetone is supplied directly from Intermediate Bulk Containers (IBCs.)
- Acetone/DMA emissions reduced through the use of dedicated abatement systems to meet EU discharge limits.