CCIT (Container Closure Integrity Testing)를 위한 교정된 마이크로 홀은 팩키징 공정의 검증에 도움이 됩니다.

Leak test는 모든 약물의 팩키징 라인에서 중요한 부분입니다. USP 1207과 EU Annex 1과 같은 제약 기준에는 패키지의 결정론적 leak testing 과정과 장비가 제대로 작동하는지 확인해야합니다. CCIT (Container Closure Integrity Testing) 또는 CCI 테스트라고도 하는 이러한 프로세스에는 양성 제어(positive control)가 필요합니다.

양성제어는 측정되어 알려진 마이크로 홀을 드릴링하여 생성됩니다. 이들은 생산 공정에서 사용되어 leak tester가 올바르게 작동하고 있다는 결정적 증거를 제공합니다.

Oxford Lasers에는 유리와 플라스틱 같은 까다로운 재료를 비롯한 다양한 재료를 가공하도록 설계, 제작된 많은 레이저 미세 가공 시스템을 갖추고 있습니다. 따라서 glass vial, glass ampule, plastic vials, blister pack, bag 및 기타 약물 용기에 5um에서 100um (또는 그 이상)의 micro hole을 뚫을 수 있습니다. Oxford Lasers의 미세 가공 시스템은 또한 바이알의 neck, body 또는 바닥 등 패키지의 여러 위치에서 드릴링할 수 있습니다. .

당사는 또한 강철에 정밀한 pin hole을 제공합니다. 이 3mm 디스크는 더 크고 덜 정밀한 hole 위의 blister pack 및 plastic pack과 같은 제품에 달라 붙습니다.

Oxford Lasers는 현재 전 세계의 최종 제약 사용자, leak tester OEM, 제약 및 의료 프로세스 컨설턴트에게 CCIT 및 leak testing을 위한 마이크로 홀을 공급하고 있습니다. 

FAQs for Direct Drilling of Glass Vials

What types of glass vials can you drill?

• We can drill any types of glass.

What is the smallest calibrated hole you can drill in a glass vial?

• Our standard service offering provides holes down to 5 microns in standard glass vials.  Other sizes are available, but these are of a non-standard specification. Please speak with a representative for more details.

Does hole location matter?

• Yes and No. A leak hole anywhere in the part will show up under test, however, the material thickness on seam lines and welds can vary by up to 1mm or more, resulting in out-of-spec hole sizes. Therefore, we would usually recommend hole locations for minimal variation in material thickness and maximum yield of parts.     

Can you drill glass vials that contain liquid?

• Providing there is a sufficient air gap (1-2mm), and the liquid inside is not hazardous (we would require Data Sheets to confirm this) we can still drill your parts.

How is the drilled hole protected for shipping and handling?

• The holes are drilled, cleaned and inspected and then covered with a low tack film.  This is easily removed prior to use leaving no residue on your vial.  We also repack all parts in the original packaging as supplied to us.

What certification do you supply with my glass vial?

• We supply a Certificate of Conformity with your delivered glass vials as standard.

Do you charge for the Certificate of Conformity?

• Our C of C’s are supplied free of charge with all glass vials.

Can I have a more comprehensive Quality Report?

• We are able to offer a more in-depth report detailing our procedure, equipment used (traceable to National Standards), and a representative sample of hole measurements and images of the drilled glass vials for a small additional cost.

Do I need a report for each vial drilled?

• The report covers the entire batch of glass vials on your order, regardless of quantities.

FAQs for Direct Drilling of Plastic Ampoules

What plastics can you drill?

• Polyethylene (PE) and Polypropylene (PP) ampoules are the most commonly requested, however we can drill any type of plastic.   

What is the smallest calibrated hole you can drill in a plastic ampoule?

• Our standard service offering provides holes down to 5 microns in standard ampoules.  Other sizes are available, but these are of a non-standard specification. Please speak with a representative for more details.

Does hole location matter?

• Yes and No. A leak hole anywhere in the part will show up under test, however, the material thickness on seam lines and welds can vary by up to 1mm or more, resulting in out-of-spec hole sizes. Therefore, we would usually recommend hole locations for minimal variation in material thickness and maximum yield of parts.

Can you drill parts that contain liquid?

• Providing there is a sufficient air gap (1-2mm), and the liquid inside is not hazardous (we would require Data Sheets to confirm this) we can still drill your parts.

How is the drilled hole protected for shipping and handling?

• The holes are drilled, cleaned and inspected and then covered with a low tack film.  This is easily removed prior to use leaving no residue on your vial.  We also repack all parts in the original packaging as supplied to us.

What Certification do you supply with my part?

• We supply a Certificate of Conformity with your delivered parts as standard.

Do you charge for the Certificate of Conformity?

• Our C of C’s are supplied free of charge with all drilled parts.

Can I have a more comprehensive Quality Report?

• We are able to offer a more in-depth report detailing our procedure, equipment used (traceable to National Standards), and a representative sample of hole measurements and images of parts drilled for a small additional cost.

Do I need a report for each part?

• The report covers the entire batch of parts on your order, regardless of quantities.