Welcome to the Frequently Asked Questions (FAQ page). Below, we have tried to answer the most common questions visitors to this our Web site may have. If you find that your question is not answered on this page, please e-mail us sanni@globepharma.com or call us during business hours at 1-732-819-0381.

  1. How can we reduce the sampling error?
  2. Are the samplers made of FDA approved materials?
  3. Are the samplers approved by FDA?
  4. Are the samplers passivated?
  5. How soon can we get the sampler once we order?
  6. How heavy is the sampler?
  7. Can we return the sampler if it is not the right one for us?
  8. Can we try the sampler before buying?
  9. How do we take proper care of the samplers?
  1. How can we reduce the sampling error?
    The sampling error may be significantly reduced by following the tips given below:
     
    • Follow the SOP provided by us when you bought the sampler.
    • Perform sampling as soon as the blending operation is done or as soon as the blend is discharged into drums or bins. This way the blend is loose (not packed) and insertion of the sampler is easier. If the blend is allowed to sit for sometime before sampling, then the blend will pack and force has to be applied to insert the sampler. Also, if the blend is packed, the sampler has to be wiggled sideways to loosen the powder and this may disturb the true uniformity of the powder blend.
    • If possible, insert the sampler into the powder at an angle so that the powder will flow freely into the die cavities.
    • Do not wiggle the sampler sideways after insertion into the powder. This may give false content uniformity results by disturbing the powder.
    • Always remove any excess powder from the outer and the inner tubes of the sampler simply by inverting them before using the sampler again for sampling. This step is very important especially when you are using duplicate and triplicate design samplers. This will also help reduce any binding problem between the two tubes.
    • Use the manual tablet compaction machine and split dies so that the powder samples may be compacted into real tablets before submission for analytical testing. This step will reduce or eliminate the errors caused by sample handling.
       
  2. Are the samplers made of FDA approved materials?
     
    • The materials of construction of the samplers are 316 SS and FDA approved plastics such as Teflon and Delrin.
       
  3. Are the samplers approved by FDA?
     
    • FDA does not approve any equipment used in manufacturing or testing. It is up to the customer to prove to FDA that they are using appropriate equipment.
       
  4. Are the samplers passivated?
     
    • The samplers are passivated using ASTM method.
       
  5. How soon can we get the sampler once we order?
     
    • The stock samplers can be shipped the same day or next day. However, most of the samplers are custom-made and in this case it takes 2-4 weeks to ship.
       
  6. How heavy is the sampler?
     
    • It depends on the model and the length of the sampler. We tried to balance between the weight of the sampler and the delicateness of the sampler. If the sampler has thick walls, then the weight is going to be higher and, on the other hand, if the sampler has thin walls, it will be lighter but it is also going to be delicate. The samplers should be considered delicate devices and care should be exercised while handling and operating them. For example, the sampler should not be wiggled once it is inserted into the powder bed; otherwise, it may bend. Also, after sampling is done and the sampler is cleaned, it should be stored horizontally inside the PVC tube.
       
  7. Can we return the sampler if it is not the right one for us?
     
    • If it is not used we may accept a return if it is done within 30 days of buying and in such a case all the shipping costs will be borne by the customer. However, if the sampler is used, we cannot take it back because of cleaning validation concerns.
       
  8. Can we try the sampler before buying?
     
    • Depending on the situation we may be able to provide a sampler for trial provided it is a stock sampler. 
       
  9. How do we take proper care of the samplers?
     
    • The samplers are delicate devices made of stainless steel tubes. The tubes are used so that the samplers are not too heavy for operation. Therefore, it is imperative that care is exercised while using, cleaning and storing the samplers.
      Following tips may be useful:
       
      • Do not wiggle the sampler in the powder bed during sampling. This may allow the sampler to bend. Once the sampler is bent, the outer and the inner tubes of the sampler may grind against each other, which in turn, may give off metal particles. CAUTION: Do not use the sampler if the tubes are bent.
      • Clean the sampler thoroughly as per your validated cleaning procedures exercising care. It would be better if the sampler is dried with clean compressed air before storing it away.
      • Always store the sampler in a clean PVC storage tube. PVC storage tubes are supplied by GlobePharma.
      • Store the sampler horizontally in the storage tube.

 

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