MOLDED VIALS & BOTTLES
Why SGD’s bottles are the best in class?
SGD is the first manufacturer of molded bottles for the pharmaceutical market in the world so we’re the leader in technology and innovation. With our trademark Asolvex, the unique type I glass with low aluminium level, can be used with sensitive products. Asolvex bottles are more resistant to mechanical shocks and withstand thermal shock of 60 degree Celsius, ensuring sterilization. Additionally, it could prolong the product’s shelf life. Therefore, SGD is a trusted and preferred supplier from the leading pharmaceutical companies around the world.
What products do SGD offer?
SGD offers injectable molded vials type I, II, III, tubular vials, ampoules and infusion bottles. SGD also offers a wide range of syrup bottles, tablet bottles, droppers, and aerosols and sprays.
What kind of raw materials does SGD use?
SGD only uses the raw materials from qualified suppliers. We’re proud to say that only a few suppliers in the world passed SGD requirements. Furthermore, unlike other manufacturers, SGD only uses internal recycled glass (cullets) and not any other external sources. As a result, the cleanliness and purity of SGD glass bottles are at its best and worry-free from contamination.
How many plants does SGD have?
Currently, SGD has 5 production facilities in both Europe and Asia. The latest type I plant is located at Saint Quentin la Motte, France.
What certificates does SGD hold?
SGD plants are certified ISO9001, ISO 15378 GMP, ISO14001, and OHSAS18001. Furthermore, all types of parenteral vials and infusion bottles offered by SGD are complied with EP and US Pharmacopoeias.
TUBULAR VIALS & AMPOULES
Why should you choose Tubular vials & Ampoules from SGD?
SGD is flexible and able to offer tubular vials and ampoules according to the customers’ requirements. Not only can we offer standard ISO items, but also tailor-made vials and ampoules per clients’ drawings. Furthermore, we can supply the glass tubes from various reputable suppliers. For example, Japanese customers may choose Nipro or NEG’s glass tubes. European and American customers may choose Schott and Corning respectively. Additionally, SGD uses ‘state-of-the-art’ conversion machines with latest technology from European countries. Therefore, you can be assured that SGD’s products are the best in market.
What type of neck finishes for tubular vials can SGD offer?
SGD can manufacture according to customer’s specification. In general, the popular neck finishes for tubular vials are:
- Crimp neck
- US Blowback
- European Blowback
- Screw neck
Why SGD’s tubular vials are suitable for Freeze-Dry process (Lyophilization)?
SGD‘s vials for lyophilization offer flat bottom and optimized radius on the vial bottomto provide the optimum lyophilization results. This design helps to prevent breakage and improve efficiency during freezing process. The blowback neck finish options also help prevent pop up of the stoppers during the cycle.
What inspection method does SGD use during production process?
SGD uses 100% on-line camera inspection and electromechanical gauge controlled by advanced software from the forming process until the final inspection. Therefore, every tubular vials and ampoules will be inspected, and rejected if any non-conformity is found.
How many types of Ampoules do SGD offer?
There are 3 kinds of ampoules which are
- From B – Stem cut. Traditional ampoules that wide-spread in the past
- Form C – Open funnel.
- Form D – Closed ampoule. The most cleanliness type of ampoule.
Should Form D be used to fill the products without washing?
Only ampoules Form D that are blown with compressed air purity class ISO8573-1: class 1 should be used without washing and autoclaving. SGD is proud to be one of few manufacturers who can offer Form D ampoule that meet ISO8573-1.
Which break system is the most popular?
SGD offer a variety of ampoule’s break systems. 2 of the most popular systems are OPC (One Point Cut) and CBR (Color Break Ring). OPC is a newer system which uses less breaking force than CBR. CBR is a traditional system and uses colored ring to determine the breaking point. Optionally, with both systems, users can choose up to 3 colors of ring coding as identifier of an assortment of products.
RUBBER STOPPERS & CAPS
Why should you choose Datwyler’s stoppers and caps?
Datwyler Pharma Packaging is the leading stoppers & closures manufacturer in Europe. At Datwyler, quality is our priority. We handpick raw materials and have a very strict production process to ensure the safety and reliability of all products delivered to our customers. Undoubtedly, Datwyler is trusted by the leading pharmaceutical companies around the world.
What products does Datwyler offer?
Datwyler offers serum stoppers, infusion stoppers in Bromobutyl and Chlorobutyl compound, Lyophilization stoppers, Nitrile stoppers, plungers, aluminium caps and flip caps. Datwyler also offers rubber components for dental cartridge and blood collection stoppers.
What kind of stoppers is suitable for injectable products?
Normally, synthetic rubber called Halobutyl is used for injectable products. The most popular formulas are Bromobutyl and Chlorobutyl. Both of them have similar properties, but Bromobutyl is a bit cheaper in term of the price.
Can Datwyler’s universal formula be used with all injectable products?
Datwyler offers universal formula on both Bromobutyl and Chlorobutyl, depending on the request of customers. These formulas can be used with most of injectable products except certain items such as oil-based products.
Does Datwyler offer Nitrile stopper? / What injectable drugs should use this kind of stopper?
Yes, Datwyler’s Nitrile stopper can be used with oil-based products because it has better deterioration rate than Halobutyl stopper.
What is the shelf life of Datwyler’s stoppers?
Datwyler has organized a shelf life study for its Halobutyl and Nitrile rubbers. From the chemical and functional data according to ISO8362-2 guideline, Halobutyl and Nitrile stopper has the storage time of 7 years at ambient conditions, which complied with ISO2230 norm “Rubber products – Guidelines for storage”.
Do Datwyler’s RTU and RFS stoppers need to be washed?
No, both RTU (Ready to Use) and RFS (Ready for Sterilization) stoppers don’t need to be washed. For RTU, the stopper is available for immediate use by pharmaceutical companies because it has been washed with purified water and WFI (Water for Injection), then gamma-sterilized in which it’s double packed in vacuum-sealed bags to ensure safety and reliability of the rubber closures. For RFS, it has been washed with purified water and WFI. It’s packaged in easy to use steam sterilizable bag which is ready to autoclave.
What is the difference between flip caps and aluminium caps?
Flip cap has a plastic component on top, which is convenient to use to open the cap for injection. Because the flip caps are variety in colors, it can be used as an identifier to differentiate the products. Due to these facts, the price of flip caps is higher than aluminium caps.
