The Art of Building Biopharmaceutical Facilities: Excellence in Every Step
The biopharmaceutical industry, a multibillion-dollar powerhouse, demands the highest level of care and precision when it comes to designing and building facilities. Ensuring consistent manufacturing methods for bioprocessing equipment is crucial for maintaining the quality and reliability we expect from our medicines. Recognizing this need, the ASME introduced a standard in 1997 to guide the industry in designing and fabricating Bioprocessing Equipment (BPE). When your bioprocessing equipment requires an upgrade or a complete overhaul, ESC Process Solutions offers a comprehensive suite of services to meet your needs.
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Ensuring Quality with the Right Materials and Practices
The journey to consistent product quality begins with the meticulous selection of materials and fabrication practices. During the design phase, our engineering team references BPE standards to identify the requirements and restrictions for hygienic tubing, equipment, and instruments. This careful selection ensures cleanable surfaces and integrates pressure relief devices to safeguard the process, product, equipment, and personnel.
Our engineers also analyze raw ingredients for potential interactions with the tubing and polymeric materials, preventing contamination and reducing the risk of batch failures. This proactive approach minimizes maintenance needs and reduces downtime caused by material degradation.
Hygienic Tubing and Instrumentation
For product contact lines, our engineers choose hygienic tubing and instruments with complete product traceability. We request important documents from suppliers, such as Material Test Reports (MTRs) and Certificates of Calibration, Compliance and/or Conformance, to ensure quality and compliance with applicable traceability standards required by BPE. Upon receiving these parts, we conduct thorough visual inspections for damage and verify required markings. Quality Engineering develops a receiving inspection process, detailing visual and dimensional checks, proper markings, correct paperwork, and acceptance or rejection criteria. This process, developed in collaboration with the end user, ensures the installation of correct and compliant items.
Precision in Welding
Once materials pass inspection, our expert welding contractors begin joining the materials. Adhering to ASME B31.3 and ASME Section IX standards, Quality Engineering, the welding contractor, and the end user create a detailed welding process. This process outlines ASME code requirements, end-user specifications, and necessary training for welders. It also includes preparation methods for material joining, critical information recording, and acceptance criteria. Proper review of each weld is crucial, as poor welding practices can introduce defects and contaminants, leading to product build-up and batch failures.
Comprehensive Documentation: The Weld Record
Documenting material joining for product contact lines involves creating a weld record. This document captures how materials were joined, which materials were used, who performed the welds, and who inspected them, along with other code-required details. Quality Engineering reviews the weld record for accuracy and completeness, then compiles it with supporting documents into a turnover package (TOP) for the end user.
The Turnover Package (TOP)
The TOP is a comprehensive compilation of relevant information from the weld record, receiving inspection documents, product data sheets, installation manuals, system drawings and schematics, certificates of cleaning/passivation, training records, and calibration records. Quality Engineering collaborates with the end user to ensure the TOP includes all necessary information. Once fabrication is complete, the TOP is handed over to the end user for reference during regulatory audits or certifications.
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Exceeding Expectations
At ESC, we pride ourselves on exceeding customer expectations. The critical steps and services outlined above are just a glimpse of what our team offers when designing new or modifying existing biopharmaceutical systems. Let us help you ensure the highest quality and safety standards for your biopharmaceutical facility.