- 案例分析
巴西专业培养基媒体制造商微生物诊断bioBoaVista，已经开发了一种病毒运输培养基（MTV），以进行更有效的鼻腔测试，以诊断COVID-19。新颖的培养基使样品稳定了更长的时间。与仅持续12小时的标准盐水样品相比，在室温下最多48小时，最多可在2°C至8°C之间进行5天。
MTV用细胞培养基制备，并补充蛋白质用于病毒稳定，并添加抗生素和抗真菌剂，以抑制鼻粘膜和喉咙中存在的其他微生物的生长。这种独家配方可以通过竞争和其他现有病原体的竞争和污染来防止病毒稳定性的任何干扰。使用柔性塑料拭子收集样品，这些拭子破裂在运输管内，避免飞溅和潜在的污染。该过程比传统手段更长的时间保护样本的质量，从而实现更有效的运输和处理。
bioBoaVista的诊断测试登记NVISA, the Brazilian Health Regulatory Agency. Using entirely local production means it does not depend on imports, which is of particular importance with current limited global transport.
The Company needed to efficiently fill its tubes up to the required 3ml level. bioBoaVista chose the Flexicon PF7 bench top filling machine from Watson-Marlow Fluid Technology Group (WMFTG) for its low shear, gentle pumping action. This ensures the valuable viral transport medium is transferred undamaged with high accuracy and precision.
With current batch sizes of 2 million units, the Company plans to increase its production to four times this and as such has scaled out capacity with additional PF7 machines. By choosing Flexicon, the Company also has the option to scale up further whilst retaining confidence in the technology. The FF30 is available to semi-automate the filling and capping process.
精确，无菌填充
Bioboavista需要一种紧凑，有效的填充机制，将其专业培养基填充到诊断测试管中。PF7的精确填充从低至0.2毫升和可重复的填充精度优于0.5％，因此Bioboavista可以准确有效地将其管填充到所需的水平，而无需过分填充。
Flexicon产品是生物技术和诊断行业的首选选择，提供了无污染过程所需的无菌保证。PF7是30年以行业为中心的经验的结果，并提供了五年的保修以及智商/OQ文档，可根据要求提供协助过程验证。它旨在处理一次性流体路径，并连接到一系列平衡和打印机以进行无错误校准，以帮助遵守GMP和监管要求。
Simple to operate
The PF7 is simple to operate, with a powerful user interface to reduce the risk of errors. Its clear and intuitive colour display and large keypad facilitate ease of use when
在洁净室环境中穿上礼服。这使Bioboavista能够填充其管子，同时保持不育以满足监管要求。
扩展到扩展
The global challenge of the COVID-19 pandemic requires widespread testing to diagnose those with the virus and to limit the spread. The availability of reliable tests is therefore essential, and organisations worldwide have been developing tests and expanding their production to meet this need. bioBoaVista’s test media maintains sample stability for significantly longer, allowing samples to be taken in isolated areas and shipped back to testing facilities without degradation or contamination.
为了快速扩大公司生产的测试数量，它已将PF7填充能力提高到将平行运行的7台机器。通过扩展相同的生产线扩大能力提高能力的趋势越来越普遍，随着负担得起的一次性技术的增长，这是一种有价值的发展，在时间稀缺时可以快速扩展。
Flexicon PF7已确保生物座量可以有效地填充其病毒运输介质，以确切地填充无菌性。它的可靠性和易用性使该公司通过其他机器大大扩展其生产能力，这些机器将增加四次测试套件的数量，并促进基本的广泛测试。