As a new foreign trade service provider driven by technology transformation and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply photoinitiator 184 sourced from multiple well-known original manufacturers.
Integrating R&D capabilities with foreign trade operations, HiSiaddi has repeatedly proposed formulation optimization schemes and application improvement suggestions for photoinitiator 184 through technological transformation cooperation with factories and precise insight into market demands. Below is a consultation case of formulation optimization for photoinitiator 184 by HiSiaddi.
Contact HiSiaddi customer service if you need formulation optimization consultation services.
FINMED OY, a listed Finnish enterprise specializing in sterile medical films, produces UV coatings for medical infusion films and pharmaceutical composite films for Northern European pharmaceutical companies. After completing small-batch trial production of domestically sourced high-purity customized 184 to replace imported IGM 184, four major mass production defects emerged on production lines post large-scale launch: small molecule precipitation of coatings after high-temperature steaming, incomplete curing with sticky surface, slight yellowing of finished products, and poor dissolution/dispersion with caking during feeding. The medical films failed EU10/2011 migration and high-temperature steaming tests, forcing production line capacity reduction and shutdown.
All raw material factory delivery indicators met standards, yet manufacturers failed to locate end-use root causes. The client entrusted HiSiaddi with full-dimensional troubleshooting and rectification covering raw material quality, formulation ratio, on-site coating & curing processes, and raw material storage & feeding specifications.
Phenomenon: Fine white spots appear on film surfaces after boiling steaming; trace phenol and cyclohexanone by-products are detected in soaked simulated medicinal liquid, exceeding pharmaceutical migration limits. Root Cause: Although total impurities of customized 184 meet standards, distribution of trace free small molecule components is uneven. The client’s original formulation copied the 3.2% addition dosage of imported materials. Excess unpolymerized free initiators and cracked fragments remain in the single 184 system, migrating outward and precipitating upon heating.
Phenomenon: Thin coatings feel sticky to touch, partial loss of cross-hatch adhesion, and insufficient curing at the bottom of thick films. Root Cause: 184 is a Type I cleavage photoinitiator with strong short-wave absorption, whose free radicals are easily quenched by oxygen in air. The client’s production line only used single-wavelength UV lamps lacking long-wave energy reinforcement, with insufficient nitrogen protection opening. Free radicals on the surface were largely consumed by oxygen, causing polymerization inhibition.
Phenomenon: Color difference ΔE exceeds standards after 30 days of normal-temperature light-proof storage, failing appearance requirements for light-colored packaging. Root Cause: Trace residual catalytic impurities in domestic 184 slowly oxidize to form chromophoric groups under heating. The client’s formulation solely relied on 184 without compound stabilizers; single-component systems exhibit weaker aging resistance than modified imported composite grades.
Phenomenon: Solid 184 agglomerates locally after feeding, difficult to fully dissolve under stirring, resulting in dot particle defects on coated finished products. Root Cause: Raw materials were stored in open-air warehouses with large temperature fluctuations, causing moisture absorption and pre-crystallization of high-purity 184. Direct one-time feeding into room-temperature resin created local supersaturation and precipitated crystal particles.
1. Adjust compound synergistic ratio: Reduce the main initiator 184 dosage from original 3.2% to 2.2%, compound with a small amount of low-migration long-wave modified additives. Adopt a dual system of short-wave 184 + long-wave auxiliary initiators: 184 enables rapid surface curing, while auxiliary additives supplement long-wave absorption for deep layers. Lower single-component addition drastically reduces residual unreacted free initiators, controlling high-temperature precipitation at the source.
2. Add 0.25% medical-grade thermal stabilizer to inhibit oxidative color formation of trace impurities and eliminate hidden yellowing risks during long-term storage. The additive complies with EU food contact regulations.
1. Optimize UV lamp group configuration by adding a small number of long-wave UV lamps to balance surface and deep-layer curing; moderately increase nitrogen protection concentration on production lines to reduce surface oxygen inhibition and completely eliminate sticky coatings.
2. Adjust line speed and lamp power sectionally to match the photolysis rate of domestic 184, avoiding incomplete curing from excessive line speed or accelerated raw material decomposition and yellowing from insufficient speed.
1. Guide the client to build a constant-temperature light-proof raw material warehouse (15–25°C). Unopened original iron drums are stored at constant temperature to prevent moisture absorption and caking caused by day-night temperature differences.
2. Feeding process: Preheat resin to 45°C, add 184 in small batches multiple times, stir at low speed for 30 minutes before high-speed dispersion to fully eliminate agglomeration and fish-eye defects.
Synchronously feed back data on raw material by-product distribution to manufacturers, coordinate fine-tuning of rectification fractionation intervals and optimization of crystallization processes to continuously improve uniformity of trace impurities in subsequent batches of raw materials.
1. After rectification, all batches of medical films show no precipitation after 121°C steaming, with liquid migration and odor fully complying with EU10/2011 pharmaceutical standards, passing incoming material audits by the Finnish Food and Drug Administration;
2. Coating surfaces become dry and non-sticky, full-layer curing achieved for both thin and thick films with cross-hatch adhesion reaching Grade 0. No obvious yellowing occurs after normal-temperature accelerated aging; no agglomeration particles appear during slurry feeding, and product yield rises from original 78.3% to 99.4%, restoring full-load production capacity;
3. The annual 98-ton order for medical-grade 184 is delivered normally in batches. The client continues to adopt the optimized compound system recommended by HiSiaddi for its new biodegradable pharmaceutical film formulations.
1. Compliance of raw material factory delivery physical and chemical indicators does not equal end-formulation compatibility. Formulation systems designed for imported raw materials cannot be directly copied for domestic high-purity 184, as domestic raw materials differ subtly from original imported products in trace impurity distribution and photosensitive reaction rates;
2. Core value of HiSiaddi: Cover the full chain including raw material characteristic analysis, composite formulation optimization, on-site coating & curing process rectification, and raw material storage & feeding standardization, balancing medical regulatory requirements, mass production processes, and raw material characteristics to resolve formulation application pain points for overseas end users;
3. Procurement of high-end medical raw materials relies not only on monomer purity indicators, but also supporting formulation technology and on-site process service, which are essential supporting conditions for domestic raw materials to replace imported alternatives.
Contact HiSiaddi customer service if you need formulation optimization consultation services.
+86-13120989737 
info@hisiaddi.com 
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