Full overview
Client Profile
| Industry |
Surgical Instruments & Medical Devices Manufacturing |
| Company Size |
Mid-to-Large Enterprise (850+ employees) |
| Geography |
Chennai, Tamil Nadu, India |
| Operational Context |
The client is engaged in the manufacturing of stainless steel surgical instruments and implant-grade components, which are distributed to local hospitals and export markets in Europe and the Middle East. Since the client components have to comply with very strict medical and regulatory standards, including visual inspection, cleanliness validation, and biocompatibility requirements, surface finish, cleanliness, and consistency become the most critical factors. |
Business Challenge
The client had various problems with their surface finishing process after the machining and forming steps, which include:
- Non-Uniform Surface Finish: By blasting with angular media, the client was creating rough surfaces and visible micro-scratches; therefore, the instruments' nice appearance was ruined.
- Hygiene & Cleanability Issues: Large surface profiles didn't allow cleaning and passivation to be carried out in an efficient manner, thus the risk of contamination was higher.
- Heavy Manual Polishing Requirement: More than 40% of the tools underwent a secondary manual polishing which raised labor costs and process variation.
- Inspection Rejections: Visual and microscopic inspections regularly found surface inconsistencies; therefore, some instruments were reworked, and deliveries were delayed.
- Regulatory Pressure: Since the client was required to adhere to ISO 13485 as well as customer-specific validation protocols, a more controlled and repeatable finishing process is absolutely necessary.
Solution Implemented
After performing several tests and examining the surface thoroughly, we came out with the recommendation of Airo Shot Blast Equipments blasting for the main surface finishing method.
Specific Solution:
- Highly pure and spherical Glass Beads of medical grade (100–180 microns) for a gentle surface peening and cosmetic finishing.
Process Customization:
- Low blast pressure to prevent metal removal and keep the instrument shape intact.
- Determined dwell time allows to attain a smooth, satin-matte finish which is perfect for surgical use.
- Separate blast equipment to eliminate any chance of cross-contamination with ferrous or aggressive media.
Application Objective:
- Getting rid of surface minor imperfections and discoloration.
- Achieving a uniform, non-directional finish.
- Enhancing the surface cleanability and the appearance before passivation and sterilization.
Implementation Process
Timeline: 5 weeks after validation trials for the complete production.
Deployment Steps:
- Week 1: Sample tests with different types of instruments (forceps, clamps, scissors).
- Week 2: Surface roughness and cleanliness evaluation before and after passivation.
- Week 3: Final decision on Airo Shot Blast Equipments size, blasting pressure, and SOP signing-off.
- Week 4: Equipment adjustment, media replacement, and clean-room-compatible workflow modifications.
- Week 5: Training the operator and paperwork for regulatory compliance.
Training: Comprehensive training was conducted for operators and QA teams on perfect media handling, contamination control, and the specifics of medical devices surface inspection standards.
Results & Impact
Using Glass Beads has brought in significant changes resulting in higher quality products and better operational efficiency:
- Finish Consistency: The instruments' batches have consistent, smooth, satin-matte finish with no variations.
- Downscaling Manual Polishing: The secondary polishing step was cut down by over 65%.
- Better Cleanability: The smoother surface helped the cleaning and passivation processes to be more effective.
- Fewer Rejections: The finish-related rejections at the inspection stage went down from 7% to less than 1%.
- Improved Brand Image: Enhanced product looks led to better feedback from customers and service audits.
ROI & Business Benefits
- Labor Cost Saving: Dependence on highly skilled manual polishers has been relaxed.
- Process Repeatability: Maintained and controlled surface finishing process confirmed to be in line with medical standards.
- Media Life Increase: Glass beads have been observed to retain their efficiency for a longer period with very little dust produced.
- Return On Investment: About 10 months based on fewer reworks, labor savings, and increased throughput.
Why the Client Chose This Company
The client chose us for the following reasons:
- We have a deep knowledge of the medical applications, which means we understand very well what the surface needs are for surgical and implant-grade components.
- Our work is always supported by evidence; therefore, the selection of media and process is always backed by well-documented and tested results from lab trials.
- We tend to achieve contamination control through our clean process designs and close attention to detail in our dedicated blasting solutions.
- We are able to provide technical support whenever needed and hence help the client continuously even through audits, product changes, and scale-up.
