HiSiaddi is an innovative foreign trade service provider driven by both technology transformation and export business. It has established a "1+2+3+4=1" service system and can supply acetyl tributyl citrate (ATBC) sourced directly from multiple well-known original manufacturers. As a foreign trader with R&D capabilities, HiSiaddi has long collaborated with manufacturers on technology conversion and accurately captured market demands, repeatedly resolving customized product requirements for ATBC clients. Below is a case illustrating how HiSiaddi addressed customized ATBC demands. For inquiries about customized services, please contact HiSiaddi customer service.
Client: MediPack AG, Switzerland (abbreviated as Company M) Core Business: Top European manufacturer of pharmaceutical packaging, sterile infusion bags and high-barrier medical films. It serves global pharmaceutical enterprises including Roche (Switzerland) and Merck (Germany). Its products are certified to ISO 13485, FDA 21 CFR and EU 10/2011 standards, with end applications covering high-risk scenarios such as injectables, blood products and infant nutritional solutions.
Procurement Requirement: Custom medical-grade acetyl tributyl citrate (ATBC) as a special plasticizer for PVC medical films, with specifications as follows: purity ≥99.8%, APHA color ≤20, heavy metals (lead/arsenic) ≤0.1ppm, free of acetylation by-products, Class 0 cytotoxicity, sterile filtration, nitrogen-sealed packaging, exclusive 5-ton single-batch customization, and full blockchain traceability.
Core Pain Points: The client contacted three domestic regular ATBC manufacturers, all of which could only supply industrial-grade standard products with purity ranging from 99.0% to 99.5% and APHA color between 30 and 50. None could fulfill the five customized requirements of ultra-high purity, low impurities, sterile processing, exclusive packaging and traceability tracking. The manufacturers lacked technical capacity to tackle technical bottlenecks including excessive by-products and poor color control, halting Company M’s customization project and exposing it to risks of supply chain disruption. The client therefore urgently commissioned HiSiaddi to deliver a solution.
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Ultra-High Purity Customization: Purity ≥99.8%, by-product (monobutyl acetyl citrate) ≤0.05% Challenge: Conventional esterification-acetylation processes adopted by ordinary manufacturers only yield 99.0%–99.5% purity with by-product content ≥0.2%, failing to meet zero-tolerance impurity standards for medical-grade materials. Risk: Migration of by-products causes precipitation on medical films and contamination of medicinal liquids, resulting in failure to pass FDA pharmaceutical filing.
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Ultra-Low Color Customization: APHA color ≤20 (colorless and transparent with no yellow tint) Challenge: Standard industrial ATBC products feature APHA color of 30–50 due to improper reaction temperature control and insufficient raw material purity, leading to slight yellow discoloration. High-end medical packaging requires ≥98% light transmittance and absolute transparency; any yellow tint renders finished products scrapped. Risk: Compromised film transparency and appearance, failing visual standards for premium medical products.
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Sterility & Low Heavy Metal Customization: Sterile filtration, heavy metals ≤0.1ppm, Class 0 cytotoxicity Challenge: Regular products undergo no sterile treatment, with heavy metal levels (lead ≤3ppm, arsenic ≤1ppm) exceeding limits and only Class 1 cytotoxicity, making them unsuitable for sterile packaging in direct contact with medicinal liquids. Risk: Contamination of medicinal liquids and human allergic reactions, violating ISO 10993 biocompatibility standards.
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Exclusive Packaging Customization: 200L sterile galvanized drums with nitrogen protection and food-grade inner coating Challenge: Conventional manufacturers only supply industrial iron drums without inner coating or nitrogen sealing, which cause product oxidation and contamination and fail medical-grade packaging specifications. Risk: Product deterioration and purity degradation during storage, precluding stable long-term preservation.
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Full-Cycle Traceability Customization: Blockchain traceability covering raw materials, production, testing and delivery Challenge: Ordinary manufacturers lack traceability systems and only provide simple Certificates of Analysis (COA), unable to satisfy Company M’s audit requirements for transparent supply chains. Risk: Inability to trace the root cause of quality defects, failing audit standards for global pharmaceutical supply chains.
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Specializing in foreign trade of medical/food-grade plasticizers, HiSiaddi boasts exclusive medical-grade ATBC factory resources, a technical team and compliance specialists, with full expertise in end-to-end customization of ATBC complying with EU and US medical standards. To resolve Company M’s five core challenges, we developed a full-process customization plan covering exclusive factory allocation, process upgrading, sterile treatment, tailored packaging and traceability system construction.
Step 1: Screen dedicated customization factories and secure medical-grade production capacity Eliminating general industrial-grade manufacturers, we selected two leading enterprises with certified medical-grade ATBC production lines from our partner roster: Shandong Langhui and Jiangsu Jiasheng. Both operate independent high-purity production workshops complying with GMP standards and supercritical extraction equipment to deliver ultra-high purity customized products. We coordinated with the factories to allocate an exclusive 5-ton dedicated production line for Company M, with separate production, independent testing and isolated packaging to avoid cross-contamination with industrial-grade products.
Step 2: Upgrade production processes to overcome technical bottlenecks of high purity and low color Jointly with factory technicians, HiSiaddi optimized manufacturing processes to achieve breakthroughs in two core indicators: Ultra-high purity optimization: Adopt a three-step refining process of secondary esterification + vacuum distillation + supercritical extraction. Precisely control reaction temperatures (esterification at 120±2℃, acetylation at 80±1℃) to thoroughly remove by-products, delivering stable purity ≥99.8% and by-product content ≤0.03%, exceeding client requirements. Ultra-low color optimization: Utilize food-grade citric acid (≥99.9%) and high-purity n-butanol as raw materials. Maintain full nitrogen protection throughout production to prevent oxidation, supplemented by deep activated carbon decolorization and precision filtration procedures. The finished product stably achieves APHA color ≤15 (surpassing the client’s ≤20 standard), appearing fully colorless and transparent with light transmittance ≥98%.
Step 3: Sterilization and low heavy metal treatment to meet biocompatibility standards Sterile filtration: Conduct 0.22μm sterile microporous membrane filtration after finishing, with sterile filling completed in a Class 10,000 clean workshop to guarantee zero microbial contamination. Heavy metal control: Deploy 316L stainless steel reactors and food-grade piping throughout production, restricting raw material heavy metal levels to lead ≤0.05ppm and arsenic ≤0.03ppm. Finished product heavy metal testing yields results ≤0.08ppm, and the material passes ISO 10993-5 cytotoxicity testing with Class 0 rating.
Step 4: Custom exclusive packaging to guarantee storage stability We coordinated packaging manufacturers to produce dedicated medical-grade packaging: Container: 200L sterile galvanized iron drums lined with food-grade epoxy resin coating to eliminate dissolution and contamination risks. Protection: Fill drums with high-purity nitrogen and seal after filling to isolate oxygen and prevent oxidation/discoloration. Marking: Drums printed with sterile labels, batch numbers, traceability QR codes and compliance certification numbers, fully compliant with medical packaging regulations.
Step 5: Build a blockchain traceability system for full-cycle tracking We partnered with Alibaba Cloud to develop an exclusive digital passport (blockchain traceability system) for Company M’s ATBC orders: Data entry: Raw material batches (citric acid/n-butanol), reaction parameters, refining records, test reports, packaging data and delivery logistics. Real-time query: Company M can track full-chain data in real time via traceability codes, supporting pharmaceutical supply chain audits and fulfilling transparent supply chain requirements.
Step 6: Authoritative testing and delivery of compliance documents for international certification recognition We arranged SGS (Swiss laboratory) to conduct full-item testing per medical-grade standards and issue official English reports, alongside a complete set of compliance documents: Test reports: Full compliance of purity, color, heavy metals, by-products, sterility and cytotoxicity indicators. Compliance documents: FDA 21 CFR filing, EU 10/2011 certification, ISO 13485 certificate, GMP certification and blockchain traceability reports.
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One-Week Small-Scale Sample Confirmation HiSiaddi supplied 5kg customized samples accompanied by full-item test reports and traceability QR codes. Company M conducted blind comparison tests, medicinal liquid compatibility tests and cytotoxicity tests, with results as follows: Purity reached 99.85%, APHA color 12, heavy metals ≤0.07ppm – all indicators outperforming products from local Swiss suppliers. The material exhibited excellent compatibility with medicinal liquids with no precipitation or contamination, and Class 0 cytotoxicity, fully meeting medical-grade specifications.
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Three-Week Bulk Custom Production & Delivery After successful sample validation, Company M issued a formal 5-ton customized order. HiSiaddi coordinated dedicated production line manufacturing with full quality monitoring: Production cycle: 3 weeks for customized manufacturing, sterile filtration, exclusive packaging and traceability data entry. Delivery method: Constant-temperature container shipping maintained at 25±5℃ to prevent product deterioration during transit. On-site acceptance: Company M conducted random inspections upon arrival, confirming 100% batch consistency and full compliance of all indicators before warehouse intake and production launch.
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Long-Term Customized Cooperation & Strategic Partnership Establishment Following delivery of the initial 5-ton batch, Company M highly recognized HiSiaddi’s customization capacity, technical expertise and compliance services, establishing long-term cooperation: Stable recurring orders: Monthly customized ATBC orders of 5–8 tons secured on dedicated production lines. Product portfolio expansion: Subsequent procurement of food-grade ATBC and medical-grade citrate plasticizers fully entrusted to HiSiaddi for customization and sourcing. Word-of-mouth referrals: Company M recommended HiSiaddi to three additional European medical packaging manufacturers, generating new mid-to-high-end clients.
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The client is a top Swiss medical packaging enterprise with core demands for ultra-high purity, low impurities, sterility, exclusive packaging and full traceability of medical-grade customized products. It is not a price-sensitive low-end buyer, with extremely stringent standards for quality, compliance and customization. Its core pain points stemmed from ordinary manufacturers’ insufficient technical capabilities, mismatched production capacity, lack of customization expertise and blank traceability systems, which failed to satisfy refined, exclusive demands of mid-to-high-end clients. HiSiaddi’s core value lies in integrating high-end production capacity, resolving technical bottlenecks, developing exclusive customized solutions, completing full compliance documentation and constructing traceability systems – evolving from a standard commodity seller to a one-stop customized solution provider for medical-grade plasticizers. The essence of our service is to precisely match the extreme requirements of mid-to-high-end clients, resolve technical and supply chain challenges, guarantee quality and regulatory compliance, and secure long-term trust through professional customization capabilities – elevating collaboration from one-off customization to strategic long-term partnerships.
For inquiries about customized services, please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
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