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Compliance

International Certification:
The company has achieved ISO 9001:2008 and US FDA cGMP for free movement of its products in USA and are fulfilling all the requirements of MDD 93/42/EEC to CE Mark on the products.

Quality Control Measures

Selection of Raw Material

In developing the top-notch instruments, Acme uses imported stainless steel of Japanese origin which is first tested according to ASTM F 899 standard. Each steel batch is purchased from a liable source possessing a recognized test certificate. Since, most of the surgical instruments require a high mechanical strength for proper functionality therefore, Acme always use harden able chromium steels with a low to medium carbon content. We always ensure a chromium content of at least 12.5% in order to guarantee sufficient corrosion resistance while undergoing it from several lab tests. Non magnet stainless steel of AISI 304 type is used for products such as instrument trays, sterilizing cassettes and trays or all finished stainless steel product types etc.

Development
At “Acme” before an instrument can be manufactured, it is designed first in the computer software according to the specifications provided. It includes several instructions and discussions with the client and the product developers. Once the design is finalized it moves into the production. Based on the technical sheets, the design then undergoes the manufacturing process.

Manufacturing
The first step in manufacturing surgical instruments is forging a blank. Our specialized smithies under geek observation forge the steel according to the required material, shape and dimension and bring it in line with the Acme standard.

Instruments then undergo through machining, fitting, filing and hardening the forge. During hardening process instruments are heated to a temperature of more than 1,000°C (1,832°F). This makes the steel hardened.

In the next step, is tempering where the instruments are kept at a temperature of about 250°C (482°F) for several hours. This treatment reduces the tension in the instruments during the forging. It also hampers the corrosion and makes the instruments very elastic.

Function and Finish
After the raw manufacturing, instruments are brought in the finishing unit. Specially trained and well experienced instrument makers in Acme, give the instruments their final shape and function. All this is done under the expert supervision of managerial staff. Highly qualified employees adapt each individual handmade instrument to its intended function. The instruments then undergo through the finishing process according to the customers specifications. Apart from conventional Dull/Matt, Sating and Silver finish, Acme also offers diamond and titanium coating on demand. Some instruments are coated in gold finish for the certain distinction during the surgical procedures.

Final Inspection and Marking
After having the finishing process done, the instruments are finally checked by trained inspectors all under the direct supervision of Production. For each instrument, written inspection instructions are laid down as criteria against which every manufacturing batch is checked. The instruments that pass this criteria move on to the marking stage. Acme has installed the latest marking and engraving machines for affixing CE Mark and customers provided labels according to the quality assurance policy which complies with the latest international standards.

Packaging
Before final packaging, each manufacturing batch is rechecked by the Director. Management also ensures that all instruments have been pre-cleaned and are free of body fluids and debris. It is then instructed to move to final packaging stage before delivery.

The instruments with sharp ends are covered with rubber tip protectors.

Instruments are then packed in zipper lock polyethylene bags. Each instrument packed carries a barcode label on the bag mentioning code, full description, size and material.

All rights reserved by Acme Surgical Industries Pvt Ltd.Copyrights © 2014                                                                       Developed By: Acme Surgical IT Department