Mangar Industries erves as a preformed pouch specialist. Using a range of materials, the ISO-certified company provides design capabilities while adhering to GMP guidelines. The optimal sterile barrier solution starts with a discussion about your device, its barrier requirements and proposed sterilization method. As an independent converter, we forge strong relationships with many premier material suppliers. We offer short lead-times, unbiased raw material recommendations and an experienced staff to assist in every phase from design to completed orders.
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Medical Pouches
Mangar is one of the largest producers of pouches for Class II and III terminally sterilized medical devices. Mangar offers an unbiased selection of material combinations and executes comprehensive quality control procedures throughout production. Customers can select from a wide variety of Tyvek®, films and foils supplied by premium material manufacturers. Mangar also offers specialty pouch configurations such as custom foil header pouches and pouches-on-a-roll used for automated-fill operations. Custom printing is also available.
Die-Cut Lids
We design variously shaped & sized lidding for sterile barrier trays. Material options for die-cut lids typically include Tyvek® or specialty foil materials. Custom printing is also available.
Mounting Cards
Medical device manufacturers can use mounting cards to properly secure and position their medical devices or components within pouches. We custom design our mounting cards to fit a wide range of devices using various tabs and folds. Standard mounting card materials include High Density Polyethylene (HDPE) and Solid Bleached Sulfate coated paperboard (SBS). Both materials are stocked by Mangar in various gauges to provide a variety of performance, sterilization method compatibility and price characteristics.
Quality
We are committed to providing quality products that are dependable and effective. Exceptional results are achieved through rigorous adherence to GMPs and a commitment to continuous quality improvement using the latest product testing technology. Customer trust and loyalty is earned by providing superior products, on time, at a competitive price, and yielding maximum value.
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ISO Certification
Mangar is ISO 13485:2003 certified and our appreciation for the importance of the products we make drives our culture of continuous process improvement and quality assurance.
ISO 11607 Compliance Support
Mangar Industries, Inc. assists customers with ISO 11607-2:2006(E) Part 2 compliance by conducting process validations for Sterile Barrier System pouches. Validations are conducted for customers using their own protocols or Mangar will initiate a protocol. Validations include full statistical analysis using Minitab® and a final report ready for a customer's ISO 11607 dossier file. All validations are supervised and approved by a Mangar Six Sigma Black Belt validation specialist.
Mangar also conducts process Design of Experiments (DOE) for customers on new material/tool combinations and prepares high/low process parameter samples for design validations.
Validations are conducted for a service fee. For a full list of validation services see below.
Validation Services:
- First Article Inspection (FAI) on tooling/pouches/lids/mounting cards
- Installation Qualification (IQ) for new tooling and equipment
- Design of Experiments (DOE) for process development
- Operational Qualification (OQ) for high/low process challenges
- Performance Qualification (PQ) analyzing three full production runs
- Consulting on ISO 11607-2:2006(E) Part 2
- pFMEA Process Failure Mode Effect Analysis
- Coordinated Package Design and Testing Services through third party affiliates