BioPharma

Whether it′s a greenfield project, a retrofit, or an upgrade, automation in the life sciences industry always includes three critical components (a) highly technical, proprietary processes, (b) timely completion (“speed to market”) and (c) regulatory compliance (e.g. FDA, EMEA, PMDA).  As such, the control and information systems as well as instrumentation solutions follow regulations and industry standards to ensure timely delivery and full compliance.

PACIV company founders, directors, and some of our associates have worked for many years within the Life Science industry.   We are well experienced in the Life Sciences’ regulated environment and the importance of ensuring that the systems we design, build, install, commission, validate and/or maintain satisfy your quality and regulatory compliance requirements, with significant focus on ensuring that the process parameters required to ensure accurate Safety, Identity, Strength, Purity, and Potency in your products is maintained.  We understand that we play a key role within your manufacturing systems to ensure accessibility to your products within the market at the expected quality.

PACIV provides a powerful combination of automation, instrumentation, validation, knowledge and experience. For over 18 years we have been engineering and implementing manufacturing and process automation projects of all sizes and types for the world’s leading pharmaceutical and biotechnology companies.  We follow industry “System Development Life Cycle” (SDLC) processes under industry guidelines (ISA S95/S88.1, ISPE GAMP™ to and C&Q BG5, ASTM E2500) to ensure our solutions are delivered as required and that they are designed, built/constructed, installed, commissioned, validated, operated, maintained, and retired following our clients’ regulatory frameworks and business risks.  In the Life Sciences regulated environment not all risks are equal.  PACIV has the needed knowledge and industry experience to properly identify potential risks and mitigate them accordingly to ensure a Risk Based Approach while delivering our clients solutions.

The life science industry and its automation solutions distinguishes itself for being forward thinking, leading edge technologies, that must be delivered and operated within a regulatory process and environment.  Ensuring consistent performance of regulatory approved and proprietary processes from one batch to  the next is of paramount importance within the industry. The products produced by this industry follow complex and proprietary processes that produce significant value for our clients and its customers, many of them lifesaving to the end user.

PACIV has played a significant role in the delivery of two of the largest Biotechnology sites in the world. We have extensive engineering and technical resources knowledgeable of the Biotech industry processes and technologies.

PACIV has established corporate agreements and strategic partnering initiatives with the Facilities and Engineering Delivery groups of the world’s leading biotech companies.  Over the past 10 years, our solutions and partnering model with our multinational clients has assisted with the significant growth of Biotech based manufactured products being deliver to patients. 

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We assist our Biotechnology clients by:

  • Providing custom solutions specifically for Life Science customers
  • Leveraging our in-depth knowledge and experience of Life Science industries
  • Provide leading advice on the applicable industry technologies and regulatory processes
  • Offering complete life cycle management through site and support services
PACIV was founded servicing this industry and has continuously developed and delivered the latest technology for such processes and systems.  PACIV supports the Operational Excellence initiatives of our clients through the deployment of our systems and technologies within a regulated environment.

PACIV has established global presence, located near our clients manufacturing sites, to provide them with the proper replication and standardization ensuring consistency of interpretation within the corporate automation standards and regulatory policies and guidelines.  By doing this, our clients have dramatically reduced the cost and time of delivering automated systems, specifically those that utilize the same technologies and similar processes.

Whether you need to automate a new plant or extract as much value as possible from existing manufacturing assets, our resources work closely with your team to identify process improvements, select the best technological solution to improve productivity, minimize risk, and manage costs. 

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We assist our Pharmaceutical clients by:

  • Replicating automation solutions across their pharma manufacturing sites
  • Assisting with the implementation of their serialization strategy and technologies
  • Global view of Pharma manufacturing sites technologies and practices
  • Applying Risk-based approach and right-sized validation efforts

  • Supporting their Operational Excellence and OEE initiatives through automated solutions
  • Offering complete life cycle management through site and support services
  • Providing up to date knowledge with the latest trends and technologies within the Pharmaceutical industry
  • Having an industry voice and active participation on Industry Standard forums (ISA, ISPE)

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