FAQs
Frequently Asked Questions
1. What does June Enterprises specialize in?
Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile product. All pharmaceutical companies that produce sterile products must comply with these regulations.
2. What Does Annex 1 says?
Section – 7.13.1
Goggle & Face Mask
Eye coverings & face should be worn to cover & enclose all facial skin.Section – 7.13 & 7.16
Sterile Glove
Sterile 400mm/600 Gloves in Nitrile & Latex, double donnable, provide extra coverage of arm, no risk of gap between garment & gloves.
Gloves compatible with alcohol & disinfectant comply with standard SOP.Section – 7.11 & 7.13.1
Disposable & Reusable Garment
Aseptically folded to comply with aseptic donning. Reusable garment should be subjected to qualification testing.Section – 7.14
Cleanroom Socks
Outdoor clothing (other than personal underwear) should not be brought into changing rooms leading directly to Grade B and C cleanrooms. Facility suits, covering the full length of the arms and the legs & socks covering the feet, should be worn before entry to change rooms for Grades B and C. Facility suits & socks should not present a risk of contamination to the gowning area or processes.Section – 4.33 & 4.34
Disinfectant
Terminology of cleaning has been replaced with “cleaning and disinfection”. Disinfection studies should be validated.Section – 8.43
Biological Indicator
Suppliers should be qualified and transportation & storage conditions should be controlled in order that BI quality is not compromised. The COA must be assessed for D-value & Z-value suitability.
3. How will June help you to comply with Annex 1?
Products manufactured by JUNE or Principle like MesaLabs (USA), Contec Inc. (USA), Isofield (Malaysia), Microbiologics (USA), AdvantaPure (USA), Eldon James (USA) etc. Comply to new regulatory standards & available locally.
4. How to Obtain Certificate of Analysis for Your Purchased June Enterprises?
You can download the Certificate of Analysis for June Enterprises products directly from the website. The CoA includes:
Microscopic, macroscopic, and phenotypic characteristics of each lot
Proof of traceability to the original Reference Culture
To access the certificate, follow the instructions provided on the Certificate of Analysis page.
If you have any questions regarding the results or data in the CoA, please contact the Technical Support Department.
5. How do I get a Statistical Analysis Certificate?
The Statistical Analysis Certificate is also available for download through the Certificate of Analysis page. This certificate includes detailed quantitative data for each microorganism lot, such as:
Mean Assay Value
Standard Deviation
Coefficient of Variation
95% and 99% Confidence Intervals
This document is specific to quantitative microorganism lots.
For any questions or clarification about the statistical results, please reach out to the Technical Support Department.
6. How to Dispose of June Enterprises Microorganisms?
Always consult your local regulatory guidelines for the proper disposal of biohazardous materials. In most cases, it is acceptable to:
Place used or expired materials in a designated biohazard waste container
Arrange for disposal through a licensed biohazard waste management company
Following these steps helps ensure safe handling and compliance with environmental and safety regulations.
If you are unsure about local requirements, contact your facility’s biosafety officer or local health authority for guidance.
