Core Services


Design to Implementation


Our Core Services are to provide the technical leadership through execution of your aseptic filling area project. Our key strengths? Those that are most important to our clients and to the process, including:

  • Subject matter expertise for fill/finish equipment procurement and installation.
  • Hands-on project resources experienced with machine operation.
  • Effective technical communication with international vendors.
  • Experienced technical writers.
  • The ability to listen, interpret, and compromise where possible.
  • The ability to acknowledge and address multi-departmental viewpoints.
  • The experience of having written and executed hundreds of FATs on a wide variety of equipment.
  • Up-to-date knowledge of the latest fill/finish technologies available.
  • Team members who are responsible, hard-working, and dedicated to you.

In general, what Core Reliance does can be summed up simply: following Good Automated Manufacturing Practice, we help our clients get the right process equipment into their facilities, and make sure they have the necessary documentation for successful, compliant operation. That simple statement hides a lot of knowledge and complexity — it takes experts like those in our company to put it into practice efficiently and correctly.

Services Overview

Here’s an overview of the scope of a typical project that Core Reliance will handle — as well as a description of the manner in which we handle it — from the earliest stages through to completion and start-up. Sometimes our clients want us to take on greater responsibility; sometimes, less. We can provide you with experienced project managers and engineers at any level of assistance.

Whichever way you prefer to work, the relationship we develop with you is of primary importance.

Phase I Process Approach

We discuss your production needs with you and help you decide on the process equipment you need.

Some of the items we discuss are: What’s the proposed layout of the line? What required machine speeds do you need to obtain your desired output? Which filling technologies are best to employ, based on your product? Is isolation technology right for you?

Phase II Validation Planning

We work with you to determine a validation strategy, and then produce a validation plan.

The main goals of our validation strategy are to:

  • Perform a GMP risk assessment.
  • Address the system components (equipment, type of control systems, and others).

The validation strategy is the basis of the validation plan. The plan addresses:

  • Activities, procedures, and responsibilities for establishing the adequacy of the system.
  • Important requirements of the vendors (which will feed into the URS).

Phase III User Requirement Specification (URS) Development

We help you define all the performance, technical, and regulatory requirements to create the URS. The URS is a critical document and is an indispensable tool in getting what we need from the vendor.

The URS will explain what the system is supposed to do. We will write it (with your input and review), and we provide it to the vendors selected for bidding. The document is maintained throughout the lifecycle of the equipment.

Phase IV Bid Analysis and Vendor Selection

We send the URS to the vendors we have all decided appropriate. We then organize the meetings to evaluate the quotes that come in, help you evaluate them, and compare them. The winning vendors will be awarded the purchase orders. Naturally, all contractual issues related to the procurement of the equipment reside with you.

Phase V Project Technical Management and Design Review

We organize the design review meetings, which are critical to the successful outcome of the project. They take place at the site of the selected vendor, with the vendor’s design engineers. The purpose of the meetings is to review and discuss, line by line, the engineering and technical details of the project, making sure that the URS is clearly understood. We will also coordinate all follow-up work.

We monitor the progress of the vendors, and we take the role of central contact between you and the vendor. As the various stages proceed (drawings, functional specifications, and further), we will review and also circulate for team reviews. We will coordinate regular project meetings among all vendors and project management, and publish meeting minutes and project schedules. In other words, we take all the day-to-day project management, so you can concentrate on your core business.

Phase VI Factory Acceptance Testing (FAT)

We develop the testing program to verify that the equipment meets the URS before it leaves the vendor’s facility.

  • We develop the testing document.
  • We manage the FAT execution.
  • We provide the execution resources, or simply provide an FAT leader, participating with your client-based execution team
  • We coordinate the component requirements (quantity, shipping, and more).
  • We publish an issues list describing any corrective actions that need to be taken by the vendor and/or you, including when these corrections must be made (prior to shipping, or prior to site acceptance testing close, or at another time). Both you and the vendor sign off on the issues list.

Phase VII Shipping/Installation/Start-Up

We support the coordination of the shipment of the equipment and coordinate or assist in the rough positioning of the equipment; we will act as the point of contact between the construction engineers and the vendor for detailed communication. The vendor is responsible for starting up the equipment and performing the system debug.

  • Site and vendor representatives will be present at the time of uncrating to check for damages.
  • Utility drops (electrical, air, and water) will be designed and installed prior to the arrival of the equipment, by your architectural & engineering firm and general contractor.
  • After rough positioning of the equipment, the vendor will be responsible for fine locating and power and utility hookup.
  • As the point of contact between the building design or construction engineers and the vendor, we will manage information about.
    > Equipment rigging and routing to the install location.
    > Utility drop locations, connection type and service details.
    > Integration details of the equipment and the building.
    > Other necessary details.

Phase VIII Equipment SOP Development and User Group Training Program

We use your existing SOP formats to develop the operational and maintenance SOPs for the equipment.

The SOPs should be in draft form before the Site Acceptance Test (SAT) is executed. We can coordinate the formal training required for the on-site mechanics and operators prior to the SAT by receiving the typical training plans from the vendors and setting up an efficient full-line training program, documented using the site’s training records.

Phase IX Commissioning / Site Acceptance

We consider the Commissioning and Site Acceptance Test to be the best and final time to catch any potential qualification protocol deviations. We develop it, coordinate its execution, publish a final report at completion, and create the punch list that results from the final report. All punch list corrections must be made and signed off on before validation of the equipment.

We develop the SAT based on the results of the FAT and the updated documentation from the vendor. We develop a SAT for 1) each piece of equipment and 2) the integrated line, verifying that all components are working correctly together. You’ll sign off on the final report before the validation step.

Phase X Validation

We develop the Installation, Operational, and Performance Qualifications (IQ, OQ, and PQ) for the equipment and integrated line, based on the requirements laid out in the validation master plan.

We can provide engineers to perform the execution of the protocols and development of the final reports; all protocols will be in the format of the user groups. Or, we can work with a validation group that you select, and provide technical support only.

Phase XI Engineering Turnover Package

This describes what we turn over to you at the close of the project — all the documents you need to have on hand for the life of the equipment.

The package generally consists of the following:

  • The validation master plan
  • Equipment URS (as built) documents
  • Equipment FDS/SDS documents
  • Executed FATs
  • Executed SATs
  • Validation documentation (if applicable)

Phase XII Commercial Start-Up and Regulator Technical Support

We can support the start-up process of the line as you begin your commercial operations.

We would undertake the following:

  • Final SOP development
  • Batch Record Development support
  • Operator and supervisor technical training
  • Process validation support
  • Aseptic process simulations (media fill) support
  • Technical descriptions of the operation for regulatory filing and reporting