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We are now certified with ISO15378:2006 GMP Certificate Number: 001-2010-15378-DNV-01 & ISO 9001:2008 Certificate Number: 79086-2010-AQ-RGC-RvA. A great number of glass, plastic containers and plastic closures are produced in clean room areas or hygienic packed by SIMONPACK and by our global suppliers. We live quality, because we draw upon the best available technology and machinery to support our quality efforts.Our manufacturing process is a blend of the finest FDA-approved raw materials, with state-of-the-art CLEANROOM system, equipments and stringent quality control procedures. All manufacturing is conducted in a sealed, clean, air-conditioned environment; even our warehousing is equipped with epoxy seamless flooring system. The Technology As one of the most vital requirements for the production of pharmaceutical bottles is clean room technology, a combination of air and filter technologies set within an environment designed especially to meet the hygienic demands of such a room.
Only highly qualified staff wearing protective clothing are allowed to enter the modular clean rooms which is entirely separated from each another. SIMONPACK became the first company in Hong Kong to injection stretch blow mould tablet and syrup containers, as well as to injection molding a wide variety of PE/PP closures in Class 1000,000 Cleanroom. Apply advanced Aoki's One step three stations injection stretch blow mold machine and Fanuc All electric injection moulding machine and Clestra Cleanroom technology
Materials used in manufacture comply with regulatory requirements with respect to Food Contact Regulations, FDA Standards and European Pharmacopoeia. Many of our containers and closures are manufactured in accordance with our rigid design and manufacturing specifications to ensure the highest degree of uniformity. Compliance with relevant monographs of the E.P. can be documented by accompanying test certificates. The bottles and caps come to the packaging clean room while they are still hot and sterile. And then they are packed in polyethylene bags. All these procedures take place in a clean air environment. Internal requirements to quality include batch registration of all items to maintain the traceability needed, packaging material specifications, and written instructions for control procedures including quarantine.
Bottles and caps are evaluated randomly; gram weights, neck dimensions, taper/concavity, wall thickness, overall dimensions, surface treatment, short shot, leak check, cycle time, color and visual. As a final check, a finished goods control according to Military Standard 105E is carried out. An ongoing and documented SOP training programs ensures that the employees possess the necessary qualifications to operate the CLEANROOM within the ISO 14644-1:1999 (E) standard. Secondary assembly operations carried out both manually and utilizing semi automatic or manual equipment. Particulate and microbiological monitoring carried out accordingly. In order to fulfill the high requirements regarding quality, SIMONPACK has achieved ISO 15378:2006 GMP under the ISO's quality scheme. The adherence to this standard is regularly examined by internal and external audits, and the discovered potential for improvement is converted also for the advantage of our products. Preventive Maintenance Program A rigid preventive maintenance program is in place to ensure the highest level of efficiency and quality from our equipment with less down time. This program helps to eliminate manufacturing defects due to equipment failure or malfunction, prior to production. Internal Audit Our audit team continuously oversees and critiques all of our manufacturing and warehousing operations. Irregularities are documented and addressed immediately. Corrective Action Should we receive a customer complaint, we will intervene on the client's behalf, communicating with the client and ensuring the problem does not recur. In addition to the above outlined procedures, our team are trained the same way in the respect of • regulatory standards, clean room imperative, traceability; Inquiries? Should you have additional questions or comments about our quality programs/systems, please contact: |
